How Did Breast Cancer Patients Fare during Different Phases of the COVID-19 Pandemic in Norway Compared to Age-Matched Controls?

Little is known about how health-related quality of life (HRQoL) in breast cancer cases differed from that of controls during and after the COVID-19 pandemic. This study used data from an ongoing, nationwide HRQoL survey of 4279 newly diagnosed breast cancer cases and 2911 controls to investigate how breast cancer patients fared during different phases of the pandemic compared to controls. Responders during 2020-2022 were categorized into three COVID-19-related phases: the social restrictions phase, the high infection rate phase, and the post-pandemic phase. Across phases, breast cancer cases had significantly worse scores in most HRQoL domains compared to controls. Apart from slightly more insomnia in the high infection rate phase for both cases and controls, and better social functioning for young cases in the post-COVID-19 phase, the case-control differences in HRQoL remained consistent across phases. When the phases were assessed as one period, young women and those living with children <18 years of age fared the worst among breast cancer cases, while single women fared the worst among controls. In contrast, controls living with children <18 years of age exhibited better HRQoL than controls without children. In summary, women with breast cancer did not appear to fare differently than controls in terms of HRQoL across COVID-19 phases. However, breast cancer cases with young children fared worse in their HRQoL than other breast cancer cases.

Compas-Y: A mixed methods pilot evaluation of a mobile self-compassion training for people with newly diagnosed cancer.

Objective: Compas-Y is a compassionate mind training app that was co-designed to be fully adapted to mobile technology and to people with newly diagnosed cancer. This study aimed to evaluate the use, appreciation and impact of the app. Methods: Seventy-one people with cancer who created an app account were included (38% breast cancer, 72% diagnosed <4 months ago, 76% received chemotherapy). Participants had very high baseline scores of self-compassion. In a convergent mixed methods design, back-end log-data (n = 71), pre-post surveys (n = 34) and semi-structured interviews (n = 23) collected for >8 weeks and were concurrently analysed using joint displays. Results: About half of the participants (45%) used 4 of the 6 modules. Compas-Y was highly appreciated, with all content considered relevant and a source of support. Experienced benefits related to improved mental health. Particularly, we found significant changes in anxiety, but not in depression or well-being. In the interviews, people reported experiencing more rest and more positive emotions due to using the app. Process benefits included significant reductions in self-criticism (inadequate self and self-blame), but not self-compassion. In the interviews, people reported improved self-compassion and less self-criticism, more self-awareness, recognition and support, and improved emotion regulation and coping. The surveys did not capture the full range of outcomes that participants reported in the interviews. Conclusions: Compas-Y is a highly appreciated mobile intervention that supported users in aspects of their mental health. Findings are discussed in terms of reach and adherence, app functionalities, co-design and tailoring of cancer-related and compassion-based eHealth.

Digital Cognitive Behavioral- and Mindfulness-Based Stress-Management Interventions for Survivors of Breast Cancer: Development Study.

BACKGROUND: Psychosocial stress-management interventions can reduce stress and distress and improve the quality of life for survivors of cancer. As these in-person interventions are not always offered or accessible, evidence-informed digital stress-management interventions may have the potential to improve outreach of psychosocial support for survivors of cancer. Few such digital interventions exist so far, few if any have been developed specifically for survivors of breast cancer, and few if any have attempted to explore more than 1 distinct type of intervention framework. OBJECTIVE: This study aimed to develop 2 digital psychosocial stress-management interventions for survivors of breast cancer; 1 cognitive behavioral therapy-based intervention (CBI), and 1 mindfulness-based intervention (MBI). METHODS: The development of the CBI and MBI interventions originated from the existing StressProffen program, a digital stress-management intervention program for survivors of cancer, based on a primarily cognitive behavioral therapeutic concept. Development processes entailed a multidisciplinary design approach and were iteratively conducted in close collaboration between key stakeholders, including experts within psychosocial oncology, cancer epidemiology, stress-management, and eHealth as well as survivors of breast cancer and health care providers. Core psychosocial oncology stress-management and cancer epidemiology experts first conducted a series of workshops to identify cognitive behavioral and mindfulness specific StressProffen content, overlapping psychoeducational content, and areas where development and incorporation of new material were needed. Following the program content adaptation and development phase, phases related to user testing of new content and technical, privacy, security, and ethical aspects and adjustments ensued. Intervention content for the distinct CBI and MBI interventions was refined in iterative user-centered design processes and adjusted to electronic format through stakeholder-centered iterations. RESULTS: For the CBI version, the mindfulness-based content of the original StressProffen was removed, and for the MBI version, cognitive behavioral content was removed. Varying degrees of new content were created for both versions, using a similar layout as for the original StressProffen program. New content and new exercises in particular were tested by survivors of breast cancer and a project-related editorial team, resulting in subsequent user centered adjustments, including ensuring auditory versions and adequate explanations before less intuitive sections. Other improvements included implementing a standard closing sentence to round off every exercise, and allowing participants to choose the length of some of the mindfulness exercises. A legal disclaimer and a description of data collection, user rights and study contact information were included to meet ethical, privacy, and security requirements. CONCLUSIONS: This study shows how theory specific (ie, CBI and MBI) digital stress-management interventions for survivors of breast cancer can be developed through extensive collaborations between key stakeholders, including scientists, health care providers, and survivors of breast cancer. Offering a variety of evidence-informed stress-management approaches may potentially increase interest for outreach and impact of psychosocial interventions for survivors of cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/47195.

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

BACKGROUND: Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions. OBJECTIVE: This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain. METHODS: Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables. RESULTS: The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference -0.90; P=.03) and self-regulatory fatigue (mean difference -2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%). CONCLUSIONS: Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Early Labour App: Developing a practice-based mobile health application for digital early labour support.

BACKGROUND: Pregnant women in early labour have felt excluded from professional care, and their partners have been restricted from being involved in the birthing process. Expectant parents must be better prepared to deal with fear and stress during early labour. There is a need for evidence-based information and digital applications that can empower couples during childbirth. OBJECTIVE: To develop and identify requirements for a practice-based mobile health (mHealth) application for Digital Early Labour Support. METHODS: This research started with creating an expert group composed of a multidisciplinary team capable of informing the app development process on evidence-based practices. In consultation with the expert group, the app was built using an agile development approach (i.e., Scrum) within a continuous software engineering setting (i.e., CI/CD, DevOps), also including user and security tests. RESULTS: During the development of the Early Labour App, two main types of challenges emerged: (1) user challenges, related to understanding the users' needs and experience with the app, and (2) team challenges, related to the software development team in particular, and the necessary skills for translating an early labour intervention into a digital solution. This study reaffirms the importance of midwife support via blended care and the opportunity of complementing it with an app. The Early Labour App was easy to use, the women needed little to no help, and the partner's preparation was facilitated. The combination of the app together with blended care opens up awareness, thoughts and feelings about the method and provides good preparation for the birth. CONCLUSION: We propose the creation of the Early Labour App, a mHealth app for early labour support. The preliminary tests conducted for the Early Labour App show that the app is mature, allowing it to be used in the project's Randomised Control Trial, which is already ongoing.

A mobile application for early labour support -feasibility pilot study.

BACKGROUND: Use of mobile applications (apps) are increasing during pregnancy but few of these are evidence-based or evaluated in research. AIM: To examine the feasibility, including perceived usefulness and usability, and the preliminary effects of an app based on the Confident birth method. METHODS: A mixed-method approach, including 48 women, was used to evaluate acceptability, usability and to test study design and procedures. iPhone-users (n = 24) tested the app during pregnancy while the remaining (n = 24) formed a control group. Background characteristics and outcome measurements were collected from all women at baseline. Women in the app group received two follow-up phone calls from a midwife concerning usefulness and ease of use of the app. A follow-up questionnaire after birth were used to measure preliminary effects of the intervention as well as system usability of the app. RESULTS: Women using the app found the app exercises simple, understandable, and useful. System usability score showed a mean score of 85.3 indicating excellent system usability. Notes from phone calls resulted in four categories: positive feedback about the app, negative feedback about the app, partners involvement, and knowledge. Preliminary effects of labour experience showed no significant differences between the two groups, in terms of early labour or childbirth experience. CONCLUSION: The app tested in this feasibility study, was perceived as useful and appreciated by women. Areas for improvement of the app were identified. The result shows promise for further efficacy testing in a forthcoming randomised controlled trial.

Acceptability and Initial Adoption of the Heart Observation App for Infants With Congenital Heart Disease: Qualitative Study.

BACKGROUND: Approximately 1% of all infants are born with a congenital heart disease (CHD). Internationally CHD remains a major cause of infant death, some of which occur unexpectedly after a gradual deterioration at home. Many parents find it difficult to recognize worsening of symptoms. OBJECTIVE: This study aims to report the acceptability and initial adoption of a mobile app, the Heart Observation app (HOBS), aiming to support parents' understanding and management of their child's condition and to increase quality in follow-up from health care professionals in complex health care services in Norway. METHODS: A total of 9 families were interviewed on discharge from the neonatal intensive care unit and after 1 month at home. The infant's primary nurse, community nurse, and cardiologist were also interviewed regarding their experiences about collaboration with the family. The interviews were analyzed inductively with thematic content analysis. RESULTS: The analysis generated 4 main themes related to acceptability and adoption: (1) Individualize Initial Support, (2) Developing Confidence and Coping, (3) Normalize When Appropriate, and (4) Implementation in a Complex Service Pathway. The receptivity of parents to learn and attend in the intervention differs according to their present situation. Health care professionals emphasized the importance of adapting the introduction and guidance to parents' receptivity to ensure comprehension, self-efficacy, and thereby acceptance before discharge (Individualize Initial Support). Parents perceived that HOBS served them well and nurtured confidence by teaching them what to be aware of. Health care professionals reported most parents as confident and informed. This potential effect increased the possibility of adoption (Developing Confidence and Coping). Parents expressed that HOBS was not an "everyday app" and wanted to normalize everyday life when appropriate. Health care professionals suggested differentiating use according to severity and reducing assessments after recovery to adapt the burden of assessments when appropriate (Normalize When Appropriate). Health care professionals' attitude to implement HOBS in their services was positive. They perceived HOBS as useful to systemize guidance, to enhance communication regarding an infant's condition, and to increase understanding of heart defects in health care professionals with sparse experience (Implementation in a Complex Service Pathway). CONCLUSIONS: This feasibility study shows that both parents and health care professionals found HOBS as a positive addition to the health care system and follow-up. HOBS was accepted and potentially useful, but health care professionals should guide parents initially to ensure comprehension and adapt timing to parents' receptivity. By doing so, parents may be confident to know what to look for regarding their child's health and cope at home. Differentiating between various diagnoses and severity is important to support normalization when appropriate. Further controlled studies are needed to assess adoption, usefulness, and benefits in the health care system.

The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study.

BACKGROUND: Family caregivers of patients who are critically ill have a high prevalence of short- and long-term symptoms, such as fatigue, anxiety, depression, symptoms of posttraumatic stress, and complicated grief. These adverse consequences following a loved one's admission to an intensive care unit (ICU) are also known as post-intensive care syndrome-family. Approaches such as family-centered care provide recommendations for improving the care of patients and families, but models for family caregiver follow-up are often lacking. OBJECTIVE: This study aims to develop a model for structuring and individualizing the follow-up of family caregivers of patients who are critically ill, starting from the patients' ICU admission to after their discharge or death. METHODS: The model was developed through a participatory co-design approach using a 2-phased iterative process. First, the preparation phase included a meeting with stakeholders (n=4) for organizational anchoring and planning, a literature search, and interviews with former family caregivers (n=8). In the subsequent development phase, the model was iteratively created through workshops with stakeholders (n=10) and user testing with former family caregivers (n=4) and experienced ICU nurses (n=11). RESULTS: The interviews revealed how being present with the patient and receiving adequate information and emotional care were highly important for family caregivers at an ICU. The literature search underlined the overwhelming and uncertain situation for the family caregivers and identified recommendations for follow-up. On the basis of these recommendations and findings from the interviews, workshops, and user testing, The Caregiver Pathway model was developed, encompassing 4 steps: within the first few days of the patient's ICU stay, the family caregivers will be offered to complete a digital assessment tool mapping their needs and challenges, followed by a conversation with an ICU nurse; when the patient leaves the ICU, a card containing information and support will be handed out to the family caregivers; shortly after the ICU stay, family caregivers will be offered a discharge conversation by phone, focusing on how they are doing and whether they have any questions or concerns; and within 3 months after the ICU stay, an individual follow-up conversation will be offered. Family caregivers will be invited to talk about memories from the ICU and reflect upon the ICU stay, and they will also be able to talk about their current situation and receive information about relevant support. CONCLUSIONS: This study illustrates how existing evidence and stakeholder input can be combined to create a model for family caregiver follow-up at an ICU. The Caregiver Pathway can help ICU nurses improve family caregiver follow-up and aid in promoting family-centered care, potentially also being transferrable to other types of family caregiver follow-up.

Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions.

BACKGROUND: One-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact their quality of life. Psychosocial stress management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) eHealth interventions. In this randomized controlled trial (RCT), Coping After Breast Cancer (CABC), 2 modified versions of the stress management eHealth intervention program StressProffen were created: one with predominantly cognitive behavioral stress management content (StressProffen-cognitive behavioral therapy intervention [StressProffen-CBI]) and another with predominantly mindfulness-based stress management content (StressProffen-mindfulness-based intervention [StressProffen-MBI]). OBJECTIVE: This study aims to investigate the effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared with a control group (treatment as usual). METHODS: Women diagnosed with breast cancer (stage I-III, unequivocally human epidermal growth factor receptor 2-positive or estrogen receptor-negative tumors) or ductal carcinoma in situ (DCIS) aged 21-69 years who completed the Cancer Registry of Norway-initiated health survey on quality of life are invited to the CABC trial about 7 months after diagnosis. Women who give consent to participate are randomized (1:1:1) to either the StressProffen-CBI, StressProffen-MBI, or control group. Both StressProffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-group changes in perceived stress at 6 months, assessed with Cohen 10-item Perceived Stress Scale. The secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness, and work-related outcomes approximately 1, 2, and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers, and mortality will be assessed using data from national health registries. RESULTS: Recruitment is scheduled from January 2021 to May 2023. The goal is to recruit 430 participants (100 in each group). As of April 14 2023, 428 participants have been enrolled. CONCLUSIONS: The CABC trial is possibly the largest ongoing psychosocial eHealth RCT in patients with breast cancer. If 1 or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen eHealth interventions could be beneficial, inexpensive, and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments. TRIAL REGISTRATION: Clinicaltrials.gov NCT04480203; https://clinicaltrials.gov/ct2/show/NCT04480203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47195.

Patient-centered development of Embrace Pain: an online acceptance and commitment therapy intervention for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy.

BACKGROUND: Around 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy, which comes with limitations in daily functioning and worsened quality of life(QoL). Treatment options are scarce. Our aim was to develop an online self-help intervention based on Acceptance and Commitment Therapy (ACT) to reduce pain interference in cancer survivors experiencing painful chronic CIPN. MATERIAL AND METHODS: This article applied a patient-centered design process using the Center for eHealth Research (CeHRes) roadmap. User needs were examined using online semi-structured interviews with patients and experts (N = 23). Interviews were transcribed verbatim and analyzed using thematic analysis. Personas were created based on interviews. Intervention content was based on identified user needs and ACT. Content and design were finalized using low-fidelity prototype testing (N = 5), and high-fidelity prototype testing (N = 7). RESULTS: Patients appreciated and agreed with the elements of ACT, had varying guidance needs, and wanted to have autonomy (e.g., moment and duration of use). Additionally, it was important to be aware that patients have had a life-threatening disease which directly relates to the symptoms they experience. Patients reported to prefer a user-friendly and accessible intervention. Similar points also emerged in the expert interviews. The final intervention, named Embrace Pain, includes six sessions. Session content is based on psychoeducation and all ACT processes. Further interpretation of the intervention (such as quotes, guidance, and multimedia choices) is based on the interviews. CONCLUSION: This development demonstrated how a patient-centered design process from a theoretical framework can be applied. Theory-driven content was used as the basis of the intervention. Findings show an online ACT intervention designed for cancer survivors with painful chronic CIPN.

Heart OBServation app: development of a decision support tool for parents of infants with severe cardiac disease.

BACKGROUND AND OBJECTIVES: Many parents of infants with CHD find it difficult to recognise symptoms of deterioration in their children. Therefore, a personalised decision support application for parents has been developed. This application aims to increase parents' awareness of their infant's normal condition, help them assess signs of deterioration, decide who and when to contact health services, and what to report. The aim of this paper is to describe the concept and report results from a usability study. METHODS: An interprofessional group developed a mobile application called the Heart OBServation app in close collaboration with parents using an iterative process. We performed a usability study consisting of semi-structured interviews of 10 families at discharge and after one month and arranged two focus group interviews with nurses caring for these families. A thematic framework analysis of the interviews explored the usability of features in the application. Usability was assessed twice using the System Usability Scale, and a user log was registered throughout the study. RESULTS: The overall system usability score, 82.3 after discharge and 81.7 after one month, indicates good system usability. The features of Heart OBServation were perceived as useful to provide tailored information, increase awareness of the child's normal condition, and to guide parents in what to look for. To empower parents, an interactive discharge checklist was added. CONCLUSIONS: The Heart OBServation demonstrated good usability and was well received by parents and nurses. Feasibility and benefits of this application in clinical practice will be investigated in further studies.

Integrating Top-down and Bottom-up Requirements in eHealth Development: The Case of a Mobile Self-compassion Intervention for People With Newly Diagnosed Cancer.

BACKGROUND: Psychosocial eHealth interventions for people with cancer are promising in reducing distress; however, their results in terms of effects and adherence rates are quite mixed. Developing interventions with a solid evidence base while still ensuring adaptation to user wishes and needs is recommended to overcome this. As most models of eHealth development are based primarily on examining user experiences (so-called bottom-up requirements), it is not clear how theory and evidence (so-called top-down requirements) may best be integrated into the development process. OBJECTIVE: This study aims to investigate the integration of top-down and bottom-up requirements in the co-design of eHealth applications by building on the development of a mobile self-compassion intervention for people with newly diagnosed cancer. METHODS: Four co-design tasks were formulated at the start of the project and adjusted and evaluated throughout: explore bottom-up experiences, reassess top-down content, incorporate bottom-up and top-down input into concrete features and design, and synergize bottom-up and top-down input into the intervention context. These tasks were executed iteratively during a series of co-design sessions over the course of 2 years, in which 15 people with cancer and 7 nurses (recruited from 2 hospitals) participated. On the basis of the sessions, a list of requirements, a final intervention design, and an evaluation of the co-design process and tasks were yielded. RESULTS: The final list of requirements included intervention content (eg, major topics of compassionate mind training such as psychoeducation about 3 emotion systems and main issues that people with cancer encounter after diagnosis such as regulating information consumption), navigation, visual design, implementation strategies, and persuasive elements. The final intervention, Compas-Y, is a mobile self-compassion training comprising 6 training modules and several supportive functionalities such as a mood tracker and persuasive elements such as push notifications. The 4 co-design tasks helped overcome challenges in the development process such as dealing with conflicting top-down and bottom-up requirements and enabled the integration of all main requirements into the design. CONCLUSIONS: This study addressed the necessary integration of top-down and bottom-up requirements into eHealth development by examining a preliminary model of 4 co-design tasks. Broader considerations regarding the design of a mobile intervention based on traditional intervention formats and merging the scientific disciplines of psychology and design research are discussed.

Organisation, influence, and impact of patient advisory boards in rehabilitation institutions-an explorative cross-sectional study.

BACKGROUND: Patient participation is highlighted as an important facilitator for patient-centered care. Patient participation organised as patient advisory boards (PABs) is an integral part of health care institutions in Norway. More knowledge is needed on how PAB representatives experience patient engagement (PE) with regard to organisation, influence, and impact. The objective was to describe how PAB representatives experience their tasks, roles, and impact on decision-making processes and service delivery in the setting of rehabilitation institutions. METHODS: PAB representatives recruited from rehabilitation institutions completed the Norwegian version of the generic Public and Patient Engagement evaluation tool (Norwegian abbreviation EBNOR). EBNOR is tested for reliability and validity with good results and comprises 35 items within four main domains, policies and practices, participatory culture, collaboration, and influence and impact that provide responses about PE-levels. The domain items are scored from "strongly disagree" to "strongly agree" on a five-point scale, in addition to a don't know category. Items in the domain "influence and impact" are scored from "never" to "all of the time" on a four-point scale. Categorical data were summarized using frequencies and percentages, and response categories were collapsed into three PE-levels: barrier, intermediate, and facilitating level. Free-text responses were analysed according to principles of manifest content analysis, summed up, and used to elaborate the results of the scores. RESULTS: Of the 150 contacted PAB representatives, 47 (32%) consented to participate. The results showed that approximately 75% agreed that the organisation as a whole was strengthened as a result of patient participation. Four out of five domains were scored indicating a facilitating level; policies and practices (53%), participatory culture (53%), collaboration and common purpose (37%), and final thoughts (63%). The modal score in the domain influence and impact was in the intermediate PE-level (44%). Of a total of 34 codes from free text analyses, barriers to PE were coded 26 times, and PE facilitators were coded 8 times. CONCLUSIONS: The findings indicate that most PAB representatives are satisfied with how rehabilitation institutions organise their PAB, but they still experience their impact as limited.

Effectiveness of the online Acceptance and Commitment Therapy intervention "Embrace Pain" for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial.

BACKGROUND: About 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy. This condition, for which treatment options are scarce, comes with limitations in daily life functioning and decreased quality of life. The current study examines the effectiveness of an online self-help intervention based on Acceptance and Commitment Therapy (ACT) in comparison to a waiting list condition (WLC) to deal with CIPN. In addition, it examines which factors moderate effects and to what extent the effects differ between guided and unguided ACT intervention. METHODS: A two-parallel, non-blinded randomized controlled trial (RCT) will be carried out. Adult cancer survivors who experience painful CIPN for at least 3 months and completed chemotherapy at least 6 months ago will be recruited (n=146). In the intervention condition, participants will follow an 8-week self-management course containing 6 modules regarding psychoeducation and ACT processes, including therapeutic email guidance. By means of text and experiential exercises, supplemented with illustrations, metaphors, and audio files, people will learn to carry out value-oriented activities in their daily life with pain. Participants will learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Participants in the WLC will be invited to follow the intervention without therapeutic guidance 5 months after start. Pain interference is the primary outcome, while psychological distress, quality of life, CIPN symptom severity, pain intensity, psychological flexibility, mindfulness skills, values-based living, and pain catastrophizing will serve as secondary outcomes. All outcome measures will be evaluated at inclusion and baseline, early-intervention, mid-intervention, post-treatment, and 3- and 6-month post-treatment. Qualitative interviews will be conducted post-treatment regarding experiences, usage, usability, content fit, and satisfaction with the intervention. DISCUSSION: This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05371158 . Registered on May 12, 2022. PROTOCOL VERSION: version 1, 24-05-2022.

The Public and Patient Engagement Evaluation Tool: forward-backwards translation and cultural adaption to Norwegian.

BACKGROUND: Patient engagement is recommended for improving health care services, and to evaluate its organisation and impact appropriate, and rigorously evaluated outcome measures are needed. METHODS: Interviews (N = 12) were conducted to assess relevance of the Canadian Public and Patient Engagement Evaluation Tool (PPEET) in a Norwegian setting were performed. The tool was translated, back translated, and assessed following cognitive interviews (N = 13), according to the COSMIN checklist. Data quality was assessed in a cross-sectional survey of patient advisory board members from different rehabilitation institutions (N = 47). RESULTS: Interviews with patient board representatives confirmed the relevance of the PPEET Organisational questionnaire in a Norwegian setting and contributed five additional items. Translation and back translation of the original PPEET showed no major content differences. Differences in vocabulary and sentence structure were solved by discussion among the translators. Comments from cognitive interviews mainly related to the use of different synonyms, layout, and minor differences in semantic structure. Results of the cross-sectional survey support the data quality and construct validity of PPEET items, including 95 score comparisons where 76 (80%) were as hypothesized. CONCLUSIONS: The PPEET Organisational questionnaire has been thoroughly translated and tested, and the resulting Evalueringsverktøy for Brukermedvirkning (EBNOR) has adequate levels of comprehensibility and content validity. Further testing for measurement properties is recommended, but given these results, the EBNOR should be considered for assessing patient engagement in a Norwegian health care organisational context.

Engaging with EPIO, a digital pain self-management program: a qualitative study.

BACKGROUND: Chronic pain conditions entail significant personal and societal burdens and improved outreach of evidence-based pain self-management programs are needed. Digital cognitive-behavioral self-management interventions have shown promise. However, evidence is still scarce and several challenges with such interventions for chronic pain exist. Exploring patients' experiences and engagement with digital interventions may be an essential step towards developing meaningful digital self-management interventions for those living with chronic pain. OBJECTIVES: This study aimed to gain insight into the experiences of people with chronic pain when engaging with EPIO, an application (app)-based cognitive-behavioral pain self-management intervention program. METHODS: Participants (N = 50) living with chronic pain received access to the EPIO intervention in a feasibility pilot-study for 3 months. During this time, all participants received a follow-up phone call at 2-3 weeks, and a subsample (n = 15) also participated in individual semi-structured interviews after 3 months. A qualitative design was used and thematic analysis was employed aiming to capture participants' experiences when engaging with the EPIO intervention program. RESULTS: Findings identifying program-related experiences and engagement were organized into three main topics, each with three sub-themes: (1) Engaging with EPIO; motivation to learn, fostering joy and enthusiasm, and helpful reminders and personalization, (2) Coping with pain in everyday life; awareness, practice and using EPIO in everyday life, and (3) The value of engaging with the EPIO program; EPIO - a friend, making peace with the presence of pain, and fostering communication and social support. CONCLUSIONS: This qualitative study explored participants' experiences and engagement with EPIO, a digital self-management intervention program for people living with chronic pain. Findings identified valued aspects related to motivation for engagement, and showed how such a program may be incorporated into daily life, and encourage a sense of acceptance, social support and relatedness. The findings highlight vital components for facilitating digital program engagement and use in support of self-management for people living with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104 .

Feasibility of a Digital Patient-Provider Communication Intervention to Support Shared Decision-Making in Chronic Health Care, InvolveMe: Pilot Study.

BACKGROUND: Enhanced communication with health care providers (HCPs) can improve symptom management and health-related quality of life (HRQoL) for patients with chronic health conditions. Access to appropriate communication venues is needed to improve communication, however. As such, digital communication interventions mediated by patient portals carry the potential to support patient-provider communication and interaction and through this, also facilitate shared decision-making (SDM). The InvolveMe intervention was designed to provide patients with the opportunity to communicate symptoms and informational needs prior to consultation via digital assessment, including prioritizing what is most important to discuss with their HCPs, as well as to interact with HCPs through secure messages between outpatient visits. OBJECTIVE: The aim of this study was to assess the feasibility of the InvolveMe intervention by investigating acceptability, demand (ie, system use), and limited efficacy. METHODS: The study was designed as a single-arm, pre-post feasibility study combining quantitative and qualitative methods for data collection. Patients from an endocrine outpatient clinic were invited to use the InvolveMe intervention for 3 months, and HCPs administering InvolveMe were invited to participate in a focus group. Guided by descriptions of how to design feasibility studies by Bowen et al, feasibility was tested by exploring (1) acceptability, using data collected during recruitment from patient participants and nonparticipants (ie, declined to participate or did not meet study requirements), HCP experiences with recruitment, and the System Usability Scale (SUS); (2) demand via exploration of system use through extraction of system log data and HCP experiences with system use; and (3) limited efficacy testing, via exploration of potential effects from the Short-Form Health Survey (RAND 36), Hospital Anxiety and Depression Scale, and Health Literacy Questionnaire. RESULTS: Patient participants (N=23) were a median 54 (range 26-78) years old and primarily male (14/23, 61%). Nonparticipants (N=16) were a median 73 (range 55-80) years old and primarily male (12/16, 75%). The average SUS score was 72.2, indicating good system usability. Assessments were completed by 8 participants from home prior to outpatient visits. The assessments entailed various bodily symptoms and needs for information. Participants sent 17 secure messages related to patient administrative matters, symptoms, and challenges. Focus group participants (N=4) were all female and registered nurses. Data were analyzed in 2 predefined themes: Acceptability and Demand. Acceptability included the subthemes intervention attractiveness and intervention suitability. Demand included the subthemes elements of SDM and intervention challenges and opportunities. All patient participants completed outcome measures at baseline, and 19 (19/23, 83%) completed outcome measures at 3 months. These preliminary efficacy findings were mixed and inconclusive. CONCLUSIONS: The study design provided findings from both patient and HCP perspectives and supported feasibility of the InvolveMe intervention. The investigation of acceptability and demand supported the potential for remote SDM mediated by patient portals using assessments and secure messages. TRIAL REGISTRATION: ClinicalTrials.gov NCT NCT04218721; https://www.clinicaltrials.gov/ct2/show/NCT04218721.

Gender and ethnicity's influence on first-year nursing students' educational motivation and career expectations: A cross-sectional study.

AIM: Given the apparent link between gender and ethnicity, and the diversity and career opportunities in nursing, this study examined gender and ethnicity's influence on first-year nursing students' educational motivation and career expectations. DESIGN: Cross-sectional. METHODS: Through bootstrapped linear regressions, we analysed data on 504 Norwegian first-year nursing students' self-reported educational motivation and career expectations, from the StudData survey at the Centre for the Study of Professions (SPS) at Oslo Metropolitan University (OsloMet). RESULTS: The sample consisted of 67 (13%) male and 437 (87%) female nursing students. Female students were more motivated compared to male students by professional interest and to pursue a specialization, less likely to assume leadership positions in the future, and more likely to prioritize family and pursue positions in the traditional nursing field. In total, 425 (84%) respondents stated a Norwegian background. Respondents who stated that both of their parents were born in a country other than Norway made up the 79 (16%) students of immigrant background. Those with immigrant backgrounds were more motivated than other students by income, status and flexible working hours and less likely to pursue a specialization or future employment in the nursing field.

Digital stress management in cancer: Testing StressProffen in a 12-month randomized controlled trial.

BACKGROUND: Cognitive-behavioral stress management interventions are associated with improved psychological well-being for cancer survivors. The availability of, access to, and outreach of these in-person interventions are limited, however. The current study, therefore, evaluated the efficacy of StressProffen, a digital application (app)-based stress management intervention for cancer survivors, in a 12-month randomized controlled trial. METHODS: Cancer survivors 1 year or less after their treatment (N = 172) were randomized to the StressProffen intervention (n = 84) or a usual-care control group (n = 88). The intervention was delivered in a simple blended care model: 1) 1 in-person introduction session, 2) 10 app-based cognitive-behavioral stress management modules, and 3) 2 follow-up phone calls. Stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18), and health-related quality of life (HRQOL; RAND-36) were examined at the baseline and at 6 and 12 months. Generalized linear models for repeated measures were fitted to compare effects over time. RESULTS: Participants were mainly female (82%), had a mean age of 52 years (standard deviation, 11.3 years; range, 20-78 years), and had a variety of cancer types (mostly breast cancer [48%]). Over the 12-month study time, the intervention group reported significantly decreased stress (P < .001), depression (P = .003), and self-regulatory fatigue (P = .002) as well as improved HRQOL (for 6 of 8 domains, P ≤ .015) in comparison with controls. The largest favored effects for the intervention group were observed at 6 months: stress (estimated mean difference [MD], -5.1; P < .001), anxiety (MD, -1.4; P = .015), depression (MD, -2.1; P < .001), self-regulatory fatigue (MD, -4.9; P < .001), and HRQOL (7 of 8 domains; P ≤ .037). CONCLUSIONS: Digital stress management interventions such as StressProffen have the potential to extend the outreach of psychological interventions and provide easily available and effective psychosocial support for cancer survivors.

A Digital Patient-Provider Communication Intervention (InvolveMe): Qualitative Study on the Implementation Preparation Based on Identified Facilitators and Barriers.

BACKGROUND: Chronic health conditions are affecting an increasing number of individuals, who experience various symptoms that decrease their quality of life. Digital communication interventions that enable patients to report their symptoms have been shown to positively impact chronic disease management by improving access to care, patient-provider communication, clinical outcomes, and health-related quality of life. These interventions have the potential to prepare patients and health care providers (HCPs) before visits and improve patient-provider communication. Despite the recent rapid development and increasing number of digital communication interventions that have shown positive research results, barriers to realizing the benefits offered through these types of interventions still exist. OBJECTIVE: The aim of this study is to prepare for the implementation of a digital patient-provider communication intervention in the daily workflow at 2 outpatient clinics by identifying potential determinants of implementation using the Consolidated Framework for Implementation Research (CFIR) to tailor the use of digital communication intervention to the intended context and identify key aspects for an implementation plan. METHODS: A combination of focus groups, workshops, and project steering committee meetings was conducted with HCPs (n=14) and patients (n=2) from 2 outpatient clinics at a university hospital. The CFIR was used to guide data collection and analysis. Transcripts, written minutes, and notes were analyzed and coded into 5 CFIR domains using thematic analysis. RESULTS: Data were examined and analyzed into 18 CFIR constructs relevant to the study purpose. On the basis of the identified determinants, important intervention tailoring includes adjustments to the digital features and adjustments to fit the clinical workflow and a decision to conduct a future pilot study. Furthermore, it was decided to provide the intervention to patients as early as possible in their disease trajectory, with tailored information about its use. Key aspects for the implementation plan encompassed maintaining the identified engagement and positive attitude, involving key stakeholders in the implementation process, and providing the needed support and training. CONCLUSIONS: This study offers insight into the involvement of stakeholders in the tailoring and implementation planning of a digital communication intervention in clinical practice. Stakeholder involvement in the identification of implementation facilitators and barriers can contribute to the tailoring of digital communication interventions and how they are used and can also inform systematic and targeted implementation planning.