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.

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.

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.

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 .

MyStrengths, a Strengths-Focused Mobile Health Tool: Participatory Design and Development.

BACKGROUND: People living with chronic illnesses are an increasingly large group. Research indicates that care and self-management should not only focus on the illness and problem-oriented aspects of these individuals' lives but also support them in recognizing and leveraging their personal strengths in daily life. OBJECTIVE: This paper presents the design and developmental process of MyStrengths, a mobile health (mHealth) app designed to help its users (people with chronic conditions) both find and make use of their personal strengths in their daily lives. Through 4 consecutive phases, this paper presents participant- and researcher-driven activities, discussions regarding design, and development of both the MyStrengths app and its content. METHODS: During the 4 phases, we used a range of methods and activities, including (1) an idea-generating workshop aimed at creating ideas for strengths-supporting features with different stakeholders, including patients, caregivers, relatives, and designers (N=35); (2) research seminars with an international group of experts (N=6), in which the concept, theoretical background, and design ideas for the app were discussed; (3) a series of co-design workshops with people in the user group (N=22) aiming to create ideas for how to, in an engaging manner, design the app; and (4) in 4 developmental iterations, the app was evaluated by people in the user group (N=13). Content and strengths exercises were worked on and honed by the research team, the expert groups, and our internal editorial team during the entire developmental process. RESULTS: The first phase found a wide range of stakeholder requirements to, and ideas for, strengths-focused mHealth apps. From reviewing literature during the second phase, we found a dearth of research on personal strengths with respect to people living with chronic illnesses. Activities during the third phase creatively provided numerous ideas and suggestions for engaging and gameful ways to develop and design the MyStrengths app. The final phase saw the output from all the earlier phases come together. Through multiple increasingly complete iterations of user evaluations testing and developing, the final prototype of the MyStrengths app was created. CONCLUSIONS: Although research supports the use of strengths-focused mHealth tools to support people living with chronic illnesses, there is little guidance as to how these tools and their content should be designed. Through all activities, we found great support among participating users for strengths-focused apps, and we can consider such apps to be both appropriate and valuable. This paper illustrates how combining a range of user-, researcher-, literature-, and designer-based methods can contribute to creating mHealth tools to support people with chronic illnesses to find and use more of their own personal strengths.

Pilot testing an app-based stress management intervention for cancer survivors.

Psychosocial eHealth intervention programs for cancer survivors are still in their infancy, with inconsistent findings so far in the scientific literature. The aim of this study was to explore system use, usefulness, ease of use, and preliminary effects of Stress Proffen, an app-based cognitive-behavioral stress management intervention for patients with cancer. A feasibility pilot project tested the intervention with cancer survivors (N = 25). The intervention contained (a) one face-to-face introduction session, (b) 10 app-based modules with stress management educational material and exercises, and (c) one follow-up phone call. Post-intervention interviews were conducted and user log-data were extracted. Outcome measures-Perceived Stress Scale (PSS), Anxiety and Depression (Hospital Anxiety and Depression Scale [HADS]), Health-Related Quality of Life (HRQoL; SF-36), and Self-Regulatory Fatigue (SRF-18)-were completed at baseline and post-intervention. Participants were primarily women (84%), age 34-71 (mean 48) and represented a variety of cancer diagnoses (majority breast cancer: 40%). Twenty-two participants completed all (pre-post) questionnaires. Sixteen participants (67%) completed at least 7 of 10 modules within the 8-week study period. Post-intervention interviews described StressProffen as providing a new, appreciated, and easily accessible stress management tool for the cancer survivors. Dependent/paired t-tests showed significant pre-post intervention effects with significant decrease in stress (p = .008), anxiety (p = .019), and self-regulatory fatigue (p = .025), and improved HRQoL (Role Physical, General Health, Vitality, and Role Emotional, all p's <.01). App-based stress management interventions such as StressProffen can provide appreciated support for cancer survivors, should be easy to use, can provide significant stress reduction, and improve emotional well-being. Further testing in a randomized controlled trial is warranted and is in progress. Clinicaltrials.gov: NCT0293961.

Spirituality and Emotional Distress Among Lung Cancer Survivors.

BACKGROUND: Emerging research is highlighting the importance of spirituality in cancer survivorship as well as the importance of early distress screening. The purpose of this study was to prospectively examine the relationships among spirituality, emotional distress, and sociodemographic variables during the early period of lung cancer survivorship. PATIENTS AND METHODS: Eight hundred sixty-four lung cancer survivors completed the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, and the Short-Form-8 for emotional distress within the first year after lung cancer diagnosis, and 474 of these survivors completed the survey again 1 year later. RESULTS: At baseline, spirituality was associated with lower prevalence of emotional distress, being married, fewer years of cigarette smoking, and better Eastern Cooperative Oncology Group performance status. Additionally, high baseline spirituality was associated with lower rates of high emotional distress at 1-year follow-up. CONCLUSION: These findings suggest that spirituality might serve as a protective factor for emotional distress among lung cancer survivors. Further research is warranted to explore the role of spirituality in promoting distress management among lung cancer survivors.

Pain is associated with reduced quality of life and functional status in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Background and aims Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is challenging to live with, often accompanied by pervasive fatigue and pain, accompanied by decreased quality of life (QoL) as well as anxiety and/or depression. Associations between higher pain, lower QoL and higher anxiety and depression have been shown in patients with various chronic pain disorders. Few studies have however examined such associations in a sample of patients with ME/CFS. The aims of the current study were to examine the impact of pain levels and compare levels of pain, health related QoL, anxiety and depression between patients with ME/CFS and healthy controls. In addition, the study aimed and to examine these relationships within the patient group only. Methods This is a cross-sectional questionnaire based study comparing 87 well-diagnosed patients with ME/CFS with 94 healthy controls. The De Paul Symptom Questionnaire (DSQ), the Medical Outcomes Study Short-Form Surveys (SF-36) and the Hospital Anxiety and Depression Scale (HADS) were used to examine and compare pain, physical function, QoL, anxiety and depression in patients and healthy controls. Further the pain variables were divided into pain total, pain intensity and a pain frequency score for analyses of the above mentioned variables within the patient group only. Results Significantly higher levels of pain, anxiety and depression, and lower levels of QoL were found in the patient group compared with healthy controls. For the patient group alone, pain was significantly associated with lower QoL in terms of physical functioning, bodily pain, general health functioning, vitality and social functioning capacity. In this patient sample, only frequency of joint pain showed significant difference in psychological variables such as depression and anxiety - depression combined. Conclusions ME/CFS patients differ significantly from healthy controls in pain, health related QoL, anxiety and depression. Pain is significantly associated with reduced QoL and overall a lower level of functioning. The relation between pain and anxiety and depression appears less clear. Implications Pain is for many ME/CFS patients associated with reduced physical functioning and reduced QoL. A thorough pain assessment can therefore be essential for clinicians, and subsequent medical pain treatment combined with good pain coping skills may increase functioning level and QoL for these patients. The link between joint pain and psychological factors should also be focused in clinical practice in terms of mapping and counseling. Pain should be further examined to understand the importance it may have for functioning level as reduced function is a main criteria when diagnosing the patients.

Self-Regulatory Fatigue: A Missing Link in Understanding Fibromyalgia and Other Chronic MultiSymptom Illnesses.

OBJECTIVE: Patients with chronic multisymptom illnesses such as fibromyalgia syndrome (FMS) are experiencing a multitude of physical and mental challenges. Facing such challenges may drain capacity to self-regulate, and research suggests patients with these illnesses may experience self-regulatory fatigue (SRF). This study sought to examine whether SRF can be associated with quality of life (QoL) in patients with FMS. METHODS: Patients (N = 258) diagnosed with FMS completed self-report measures related to demographics, SRF (Self-Regulatory Fatigue 18 [SRF-18]), anxiety (Generalized Anxiety Disorder questionnaire [GAD-7]), depression (Patient Health Questionnaire [PHQ-9]), physical fatigue (Multidimensional Fatigue Inventory [MFI]), symptoms related to FMS (Fibromyalgia Impact Questionnaire [FIQ]), and QoL (36-Item Short-Form Health Survey [SF-36]). RESULTS: Hierarchical regressions showed higher SRF to be associated with lower QoL in terms of lower overall physical QoL, with subscales related to physical functioning, role limitations-physical, bodily pain, and general health (all P's > 0.001), as well as lower overall mental QoL, with subscales related to vitality, social functioning, role limitations-emotional, and mental health (all P's > 0.001). Including traditional predictors such as anxiety, depression, physical fatigue, and FMS-related symptoms as covariates in the analyses reduced the link between SRF and QoL somewhat, but the associations remained generally strong, particularly for SRF and mental QoL. CONCLUSION: This is the first study to show higher SRF relating to lower QoL for patients with FMS. Results suggest that SRF is distinct from anxiety, depression, and fatigue, and predicts QoL above and beyond these traditional factors in the area of chronic multisymptom illnesses such as FMS. SRF may be a "missing link" in understanding the complex nature of chronic multisymptom illnesses.

Self-regulatory fatigue in chronic multisymptom illnesses: scale development, fatigue, and self-control.

BACKGROUND: Self-regulatory capacity involves ability to regulate thoughts, emotions, and behavior. Chronic multisymptom illnesses such as fibromyalgia and chronic fatigue syndrome are accompanied by numerous challenges, and have recently been associated with self-regulatory fatigue (SRF). Chronic multisymptom illnesses are also frequently associated with physical fatigue, and through development of a scale measuring SRF, the current study aimed to examine how SRF can be distinguished from physical fatigue. The study also sought to distinguish SRF from self-control. METHODS: Two self-regulation researchers developed 30 items related to self-regulatory capacity. These items were distributed to patients (n = 296) diagnosed with chronic multisymptom illness together with validated measures of physical fatigue and self-control. A principal factor analysis was employed to examine factor structures, identify inter-item relationships, and aid in scale development. RESULTS: The final proposed scale consisted of 18 items measuring self-regulatory capacity (SRF-18) with cognitive, emotional, and behavioral SRF components. Internal consistency and reliability was acceptable (Cronbach's á = 0.81). The final scale was moderately correlated with self-control (r = -0.48) and highly correlated with physical fatigue (r = 0.75), although more so with emotional (r = 0.72) and mental (r = 0.65) than physical (r = 0.46) fatigue components. CONCLUSION: The current study suggests a new scale for measurement of SRF in chronic multisymptom illness. Although cross-validation studies are necessary, such a scale may contribute to a better understanding of the concept of self-regulation and the role of SRF in chronic illness. Although related to physical fatigue and self-control, the results point to SRF as a distinct construct.

Output order reflects the cognitive accessibility of goals.

Goal accessibility--the ease or speed with which a goal is activated--increases the likelihood that it will be acted on. The present studies validate output order as a measure of goal accessibility that can be applied to goal lists in both laboratory and naturalistic settings. In three studies, output order (the order in which goals are listed in a free-response format) was related to self-reported goal value but was not redundant with it. Furthermore, output order was affected by motivational priming whereas value was not, and order associated with typical student goals (e.g., achievement) compared with atypical goals (e.g., power). Output order is well suited to bring the study of accessibility to naturalistic studies of goals and goal pursuit.

Individual differences and self-regulatory fatigue: optimism, conscientiousness, and self-consciousness.

Ability to self-regulate varies and self-regulatory strength is a limited source that can be depleted or fatigued. Research on the impact of individual differences on self-regulatory capacity is still scarce, and this study aimed to examine whether personality factors such as dispositional optimism, conscientiousness, and self-consciousness can impact or buffer self-regulatory fatigue. Participants were patients diagnosed with chronic multi-symptom illnesses (N = 50), or pain free matched controls (N = 50), randomly assigned to either a high or low self-regulation task, followed by a persistence task. Higher optimism predicted longer persistence (p = .04), and there was a trend towards the same effect for conscientiousness (p = .08). The optimism by self-regulation interaction was significant (p = .01), but rather than persisting despite self-regulatory effort, optimists persisted longer only when not experiencing self-regulatory fatigue. The effects of optimism were stronger for controls than patients. There was also a trend towards a similar conscientiousness by self-regulation interaction (p = .06). These results suggest that the well-established positive impact of optimism and conscientiousness on engagement and persistence may be diminished or reversed in the presence of self-regulatory effort or fatigue, adding an important new chapter to the self-regulation, personality, and pain literature.

Self-regulatory deficits in fibromyalgia and temporomandibular disorders.

Chronic pain conditions such as fibromyalgia (FM) and temporomandibular disorders (TMDs) are accompanied by complex interactions of cognitive, emotional, and physiological disturbances. Such conditions are complicated and draining to live with, and successful adaptation may depend on ability to self-regulate. Self-regulation involves capacity to exercise control and guide or alter reactions and behavior, abilities essential for human adjustment. Research indicates that self-regulatory strength is a limited source that can be depleted or fatigued, however, and the current study aimed to show that patients with FM and TMD are vulnerable to self-regulatory fatigue as a consequence of their condition. Patients (N=50) and pain-free matched controls (N=50) were exposed to an experimental self-regulation task followed by a persistence task. Patients displayed significantly less capacity to persist on the subsequent task compared with controls. In fact, patients exposed to low self-regulatory effort displayed similar low persistence to patients and controls exposed to high self-regulatory effort, indicating that patients with chronic pain conditions may be suffering from chronic self-regulatory fatigue. Baseline heart rate variability, blood glucose, and cortisol predicted persistence, more so for controls than for patients, and more so in the low vs. high self-regulation condition. Impact of chronic pain conditions on self-regulatory effort was mediated by pain, but not by any other factors. The current study suggests that patients with chronic pain conditions likely suffer from chronic self-regulatory fatigue, and underlines the importance of taking self-regulatory capacity into account when aiming to understand and treat these complex conditions.

Heart rate variability reflects self-regulatory strength, effort, and fatigue.

Experimental research reliably demonstrates that self-regulatory deficits are a consequence of prior self-regulatory effort. However, in naturalistic settings, although people know that they are sometimes vulnerable to saying, eating, or doing the wrong thing, they cannot accurately gauge their capacity to self-regulate at any given time. Because self-regulation and autonomic regulation colocalize in the brain, an autonomic measure, heart rate variability (HRV), could provide an index of self-regulatory strength and activity. During an experimental manipulation of self-regulation (eating carrots or cookies), HRV was elevated during high self-regulatory effort (eat carrots, resist cookies) compared with low self-regulatory effort (eat cookies, resist carrots). The experimental manipulation and higher HRV at baseline independently predicted persistence at a subsequent anagram task. HRV appears to index self-regulatory strength and effort, making it possible to study these phenomena in the field as well as the lab.

When Goals Conflict But People Prosper: The Case of Dispositional Optimism.

Optimistic persistence in pursuing goals may have beneficial consequences such as protection against negative affect and greater likelihood of goal attainment, but persistence can also result in greater likelihood of goal conflict, which can have negative consequences. Two studies, one cross-sectional (N = 100) and one longitudinal (N = 77), found that optimism associated with higher goal conflict. However, objectively rated goal conflict did not significantly undermine adjustment, and when balance among goal value, expectancy, and conflict was considered, optimism associated with better balance. In turn, balance accounted for part of optimists' better goal progress over the course of a semester. Although goal conflict may have costs, these costs appear to be offset by accompanying benefits, particularly for optimists.

Dispositional optimism and coping: a meta-analytic review.

The relation between dispositional optimism and better adjustment to diverse stressors may be attributable to optimism's effects on coping strategies. A meta-analytic review (K = 50, N = 11,629) examined the impact of dispositional optimism on coping. Dispositional optimism was found to be positively associated with approach coping strategies aiming to eliminate, reduce, or manage stressors or emotions (r = .17), and negatively associated with avoidance coping strategies seeking to ignore, avoid, or withdraw from stressors or emotions (r = -.21). Effect sizes were larger for the distinction between approach and avoidance coping strategies than for that between problem and emotion-focused coping. Meta-analytic findings also indicate that optimists may adjust their coping strategies to meet the demands of the stressors at hand, and that the optimism-coping relationship is strongest in English-speaking samples.

Engagement and arousal: optimism's effects during a brief stressor.

Optimism is usually associated with better psychological and physiological adjustment to stressors, but some contradictory findings exist. The purpose of this study was to investigate how optimism could result in negative immunological changes following difficult stressors. Because optimists are likely to see positive outcomes as attainable, they may invest greater effort to achieve their goals. It is proposed that such engagement would be more physiologically demanding when pursuing difficult goals. Participants (N = 54) worked on 11 difficult or insoluble anagrams. Optimism when combined with high self-awareness increased time spent working on the anagrams and skin conductance and salivary cortisol during the recovery period. The results support the notion that the increased engagement that arises from optimism may lead to short-term physiological costs.