Neuropsychological functioning of adults with PTEN hamartoma tumor syndrome.

PTEN hamartoma tumor syndrome (PHTS) might be associated with a distinct cognitive and psychological profile. However, previous studies are limited, predominantly based on small and pediatric cohorts, likely affected by selection bias, and show a broad range of findings. We aimed to characterize the neuropsychological functioning of adults with PHTS. A total of 40 participants, with intellectual disability as exclusion criterium, completed an extensive clinical neuropsychological assessment including cognitive tasks, questionnaires, and a clinical diagnostic interview. The cognitive tasks and questionnaire data were categorized as below and above average based on 1.5 SD. About 80% of participants showed an average level of intelligence. In addition, 30% and 24% of participants scored below average on immediate memory recall and speed of information processing, respectively. Furthermore, about 25% reported above average scores on the majority of the questionnaires, indicating psychological distress, signs of alexithymia, and cognitive complaints. Personality of participants was characterized by inflexibility, social withdrawal, and difficulties in recognizing and describing their own emotions. Adults with PHTS demonstrate a heterogeneous yet distinct neuropsychological profile that is characterized by slower information processing, psychological problems, and specific personality traits. These findings provide directions on how to optimize the care and daily lives of adults with PHTS.

Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial.

BACKGROUND: Online mindfulness based cognitive therapy (eMBCT) has been shown to reduce psychological distress in people with cancer. However, this population has reported lack of support and asynchronous communication as barriers to eMBCT, resulting in higher nonadherence rates than with face-to-face MBCT. Using a co-creation process, we developed 2 formats of eMBCT: group, blended (combination of therapist-guided group and individual online sessions) and individual, unguided (individual, unguided online sessions only). Group, blended eMBCT offers peer support and guidance, whereas individual, unguided eMBCT offers flexibility and the possibility of large-scale implementation. OBJECTIVE: The objective of this nonrandomized feasibility study was to assess aspects of feasibility of the group, blended and individual, unguided eMBCT interventions. METHODS: Participants were people with cancer who chose between group, blended and individual, unguided eMBCT. Both intervention conditions followed the same 8-week eMBCT program, including an introductory session and a silent day (10 sessions total). All sessions for individual, unguided eMBCT occurred via the platform Minddistrict, whereas group, blended eMBCT consisted of 3 online videoconference sessions guided by a mindfulness teacher and 5 sessions via Minddistrict. We assessed the feasibility of the intervention quantitatively and qualitatively by evaluating its acceptability among participants. Additionally, we assessed limited efficacy by looking at the number of questionnaires participants completed pre- and postintervention. RESULTS: We included 12 participants for each eMBCT condition. Participants in group, blended eMBCT completed, on average, 9.7 of 10 sessions, compared with an average 8.3 sessions for individual, unguided eMBCT (excluding dropouts). Of the 24 participants, 13 (54%) agreed to be interviewed (5 unguided and 8 blended). Participants in both conditions reported positive experiences, including the convenience of not having to travel and the flexibility to choose when and where to participate. However, among the barriers for participation, participants in the group, blended condition reported a preference for more group sessions, and participants in the individual, unguided condition reported a lack of guidance. Additionally, for the group, blended condition, the effect sizes were small for all outcome measures (Hedges g range=0.01-0.36), except for fatigue, which had a moderate effect size (Hedges g=0.57). For the individual, unguided condition, the effect sizes were small for all outcome measures (Hedges g range=0.24-0.46), except for mindfulness skills (Hedges g=0.52) and engagement with the intervention (Hedges g=1.53). CONCLUSIONS: Participants in this study had a positive experience with group, blended and individual, unguided eMBCT. Based on the results from this study, we will adjust the intervention prior to conducting a full-scale randomized controlled trial to evaluate effectiveness; we will add 1 group session to the group, blended eMBCT using Zoom as the platform for the group sessions; and we will send reminders to participants to complete questionnaires. TRIAL REGISTRATION: ClinicalTrials.gov NCT05336916; https://clinicaltrials.gov/ct2/show/NCT05336916.

Toward implementation of an evidence-based intervention for fear of cancer recurrence: Feasibility in real-world psycho-oncology practice.

OBJECTIVE: Few evidence-based interventions addressing high levels of fear of cancer recurrence (FCR) have been implemented. Understanding how these might be implemented is crucial to bridge the research-practice gap. This study investigated the feasibility of implementing the blended Survivors' Worries of Recurrent Disease (SWORD) intervention in real-world psycho-oncology practice. METHODS: SWORD was offered for 15 months (2021-2022) as the standard care for clinical FCR in a university hospital, a general hospital, and psycho-oncological center. We evaluated using a mixed-methods design six feasibility outcomes based on Bowen's framework: demand, limited effectiveness, degree of execution, acceptability, practicality, and integration. Anonymous data were collected for all oncology patients on referral. Study participants completed questionnaires before and after treatment, including the Cancer Worry Scale (CWS-6) as the primary measure of effectiveness. Qualitative data included interviews with patients and psychologists, and field notes. RESULTS: Regarding demand, 81 of 644 patients referred (13%) were eligible for SWORD. The uptake of SWORD was 79% (n = 63/80) and the completion rate 73% (n = 46/63). SWORD was effective in reducing FCR (p < 0.001, ηp2  = 0.694). Regarding execution, a variability in the length, planning and number of treatment sessions was found between different settings. Adherence to the treatment manual's content was high (89%). Regarding acceptability, most patients were satisfied with SWORD (average 8.2/10) and psychologists valued the blended format. Psychologists reported SWORD was practical to deliver given their knowledge and skills. Although differences between settings were found, SWORD integrated well into practice. Referral for FCR and a reluctance to contract new eHealth providers were barriers for implementation. CONCLUSIONS: Despite differences between healthcare settings, the implementation of SWORD was evaluated well. The feasibility of SWORD in different settings should inform a national implementation strategy.

Symptoms of Anxiety and Depression Among Slovenian Breast Cancer Survivors Post-Treatment During the COVID-19 Pandemic: A Cross-Sectional Study.

Background: Although anxiety and depression are important determinants of mental health, the literature in this area is sparse as most studies focus on the period during treatment. Mental health problems can affect cancer recovery as well as quality of life and survival. In this cross-sectional study, we investigated the prevalence of anxiety and depression in Slovenian cancer survivors after treatment and assessed the associated correlates during the COVID-19 pandemic. Methods: From September 2021 to January 2022, we collected data from 430 breast cancer survivors one to five years after receiving post-local treatment and (neo)adjuvant chemotherapy. We used the Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression levels. Multivariate linear regression was used to identify factors associated with higher levels of anxiety and depression. Results: Key findings from this study are increased levels of psychological distress and identification of relevant factors associated with those elevated levels. Approximately one-third of breast cancer survivors exhibited symptoms of elevated anxiety and depression, with one in eight meeting clinical thresholds. Multivariate linear regression revealed that age, lower quality of life, heightened fear of cancer recurrence (FCR), reduced resilience, limited social support, and unmet psychosocial and emotional needs correlated with increased anxiety symptoms. Additionally, lower quality of life, higher FCR, diminished resilience, and limited social support were associated with higher depression symptomatology. Conclusions: Our study of Slovenian breast cancer survivors one to five years post-treatment observed a significant increase in anxiety and depression symptoms, possibly exacerbated by the COVID-19 pandemic. The demographic and psychosocial factors identified in this study offer valuable insights for future research. The study emphasises the importance of recognising and addressing the psychological needs of breast cancer survivors and the need to follow them throughout their cancer journey.

Randomized controlled trial of an individual blended cognitive behavioral therapy to reduce psychological distress among distressed colorectal cancer survivors: The COloRectal canceR distrEss reduCTion trial.

OBJECTIVE: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. METHODS: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (1:1 ratio) to receive bCBT, (14 weeks including five face-to-face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention-to-treat population was distress severity (Brief Symptom Inventory; BSI-18) immediately post-intervention (T1). RESULTS: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention-to-treat analysis, the intervention significantly reduced distress immediately post-intervention (-3.86 points, 95% CI -7.00 to -0.73) and at 7 months post-randomization (-3.88 points, 95% CI -6.95 to -0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer-specific distress were significantly lower in the intervention arm. Self-efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. CONCLUSIONS: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. TRIAL REGISTRATION: Netherlands Trial Register NTR6025.

Key Factors in Helpfulness and Use of the SAFE Intervention for Women Experiencing Intimate Partner Violence and Abuse: Qualitative Outcomes From a Randomized Controlled Trial and Process Evaluation.

BACKGROUND: Many women experience at least one type of intimate partner violence and abuse (IPVA), and although various support options are available, we still know relatively little about web-based interventions for IPVA survivors. We conducted a qualitative evaluation of the SAFE eHealth intervention for women experiencing IPVA in the Netherlands, complementing the quantitative evaluation of self-efficacy, depression, anxiety, and multiple feasibility aspects. OBJECTIVE: This study assessed users' experiences and what, according to them, were useful and helpful aspects of the intervention. METHODS: The intervention consisted of modules with information on relationships and IPVA, help options, physical and mental health, and social support. It also contained interactive elements such as exercises, stories from survivors, a chat, and a forum. A randomized controlled trial was conducted with an intervention arm receiving the complete version of the intervention and a control arm receiving only a static version with the modules on relationships and IPVA and help options. We gathered data through open questions from surveys (for both study arms; n=65) and semistructured interviews (for the intervention study arm; n=10), all conducted on the web, during the randomized controlled trial and process evaluation. Interview data were coded following the principles of open thematic coding, and all qualitative data were analyzed using qualitative content analysis. RESULTS: Overall, most users positively rated the intervention regarding safety, content, and suiting their needs, especially participants from the intervention study arm. The intervention was helpful in the domains of acknowledgment, awareness, and support. However, participants also identified points for improvement: the availability of a simplified version for acute situations; more attention for survivors in the aftermath of ending an abusive relationship; and more information on certain topics, such as technological IPVA, support for children, and legal affairs. Furthermore, although participants expressed a prominent need for interactive contact options such as a chat or forum, the intervention study arm (the only group that had these features at their disposal) mainly used them in a passive way-reading instead of actively joining the conversation. The participants provided various reasons for this passive use. CONCLUSIONS: The positive outcomes of this study are similar to those of other web-based interventions for IPVA survivors, and specific points for improvement were identified. The availability of interactive elements seems to be of added value even when they are used passively. This study provides in-depth insight into the experiences of female IPVA survivors with the SAFE eHealth intervention and makes suggestions for improvements to SAFE and comparable web-based interventions for IPVA as well as inspiring future research. Furthermore, this study shows the importance of a varied assessment of an intervention's effectiveness to understand the real-world impact on its users. TRIAL REGISTRATION: Netherlands Trial Register NTR7313; https://tinyurl.com/3t7vwswz.

Effectiveness of the SAFE eHealth Intervention for Women Experiencing Intimate Partner Violence and Abuse: Randomized Controlled Trial, Quantitative Process Evaluation, and Open Feasibility Study.

BACKGROUND: Intimate partner violence and abuse (IPVA) is a pervasive societal issue that impacts many women globally. Web-based help options are becoming increasingly available and have the ability to eliminate certain barriers in help seeking for IPVA, especially in improving accessibility. OBJECTIVE: This study focused on the quantitative evaluation of the SAFE eHealth intervention for women IPVA survivors. METHODS: A total of 198 women who experienced IPVA participated in a randomized controlled trial and quantitative process evaluation. Participants were largely recruited on the internet and signed up through self-referral. They were allocated (blinded for the participants) to (1) the intervention group (N=99) with access to a complete version of a help website containing 4 modules on IPVA, support options, mental health, and social support, and with interactive components such as a chat, or (2) the limited-intervention control group (N=99). Data were gathered about self-efficacy, depression, anxiety, and multiple feasibility aspects. The primary outcome was self-efficacy at 6 months. The process evaluation focused on themes, such as ease of use and feeling helped. In an open feasibility study (OFS; N=170), we assessed demand, implementation, and practicality. All data for this study were collected through web-based self-report questionnaires and automatically registered web-based data such as page visits and amount of logins. RESULTS: We found no significant difference over time between groups for self-efficacy, depression, anxiety, fear of partner, awareness, and perceived support. However, both study arms showed significantly decreased scores for anxiety and fear of partner. Most participants in both groups were satisfied, but the intervention group showed significantly higher scores for suitability and feeling helped. However, we encountered high attrition for the follow-up surveys. Furthermore, the intervention was positively evaluated on multiple feasibility aspects. The average amount of logins did not significantly differ between the study arms, but participants in the intervention arm did spend significantly more time on the website. An increase in registrations during the OFS (N=170) was identified: the mean amount of registrations per month was 13.2 during the randomized controlled trial and 56.7 during the OFS. CONCLUSIONS: Our findings did not show a significant difference in outcomes between the extensive SAFE intervention and the limited-intervention control group. It is, however, difficult to quantify the real contribution of the interactive components, as the control group also had access to a limited version of the intervention for ethical reasons. Both groups were satisfied with the intervention they received, with the intervention study arm significantly more so than the control study arm. Integrated and multilayered approaches are needed to aptly quantify the impact of web-based IPVA interventions for survivors. TRIAL REGISTRATION: Netherlands Trial Register NL7108 NTR7313; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7313.

Taking Care of an Adolescent and Young Adult Cancer Survivor: A Systematic Review of the Impact of Cancer on Family Caregivers.

Research usually investigates adolescents and young adults (AYA) with cancer in combination with younger and older cancer patients and survivors. However, AYAs with cancer are a unique group, and their caregivers' experience may also differ from other caregivers of cancer survivors. This systematic review aims to understand the impact of a cancer diagnosis on family caregivers, comparing the experience of caregivers of AYA childhood cancer survivors (AYA CCS) and caregivers of AYA with cancer. Relevant studies were identified through PubMed, Scopus, and Web of Science databases, and their quality was assessed using the Joanna Briggs Institute's critical appraisal checklists. Sixteen studies (17 reports) met the inclusion criteria. Findings were synthesized separately for caregivers of AYA CCS and caregivers of AYA with cancer. Results showed that caregivers in both groups experienced high distress after the diagnosis. Partners of AYAs with cancer experienced diminished quality of life (QoL) and over half reported moderate to high fear of cancer recurrence (FCR). Findings indicated that cancer negatively impacts family caregivers, regardless of the patient's age at diagnosis. However, findings are heterogeneous, and most do not focus on QoL or FCR. More research is needed on the impact of cancer among these family caregivers.

Reasons for non-participation in a psychological intervention trial for distress in colorectal cancer survivors.

OBJECTIVE: High psychological distress is reported by one third of colorectal cancer survivors (CRCS). However, intervention studies for CRCS have reported low participation rates. In this study, reasons for non-participation and low uptake in a psychological intervention trial were investigated. METHODS: CRCS were recruited for a randomized clinical trial on the efficacy of blended cognitive behavior therapy for psychological distress via databases, follow-up consultations, advertisements and an ongoing population-based study. The recruitment flow and reasons for non-participation were analyzed for patients recruited between 2016 and 2020. Subgroups were compared based on demographic, clinical and screening data. High distress as study entry criterion was measured with the Distress Thermometer (DT ≥ 5) and the problem list (PL). RESULTS: From all recruitment methods together, 1326 CRCS responded to the invitation letter of whom 510 (38%) were interested in receiving a screening questionnaire. Interested CRCS were significantly younger than non-interested CRCS (p < 0.001). Most non-interested CRCS reported having no complaints. Of interested CRCS, 448 (88%) completed screening with the DT of which 213 (48%) CRCS scored above the DT cutoff for high distress. The majority expressed no need for help resulting in 84 (4% of eligible) CRCS included in the trial. Younger age, shorter time since diagnosis and more problems on the PL were positively related to participation. CONCLUSIONS: In this study a low participation rate was found. However, patients with high distress and most in need for help were included in the trial. For future research it is recommended to perform pilot- and feasibility studies to optimize recruitment.

Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial.

BACKGROUND: One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online interventions have been reported as barriers for treatment adherence and can result in higher drop-out rates. Considering this, two new formats of eMBCT were created. The primary objective of the Buddy trial is to evaluate the (cost) effectiveness of blended and unguided eMBCT versus care as usual (CAU) on psychological distress among cancer patients and survivors. Secondary objectives include evaluating effects on other psychological outcomes and investigating working mechanisms and treatment effect moderators. METHODS: The Buddy trial is a parallel three-armed randomized controlled trial. Participants will be randomly assigned to blended therapist-assisted eMBCT, unguided individual eMBCT or CAU. Eligible participants will be Dutch-speaking adult cancer patients or survivors with access to internet. The primary outcome will be psychological distress scores as assessed by the Hospital Anxiety and Depression scale immediately post-treatment. Secondary outcome measures include fear of cancer recurrence (FCRI), fatigue (CIS-F), rumination (RRQ), mindfulness skills (FFMQ), decentering (EQ), self-compassion (SCS-SF), positive mental health (MHCSF), health related quality of life (EQ-5D), and costs associated with psychiatric illness (TiC-P). Outcome measures will be evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up. Possible mediators, such as engagement with interventions (TWEETS), and moderators will be also analyzed. DISCUSSION: There is room to improve eMBCT for cancer patients prior to implementation to ensure adherence and scalability. Blended and unguided eMBCT may reduce psychological distress and improve quality of life and be easily accessible to cancer patients and survivors. Trial registration clinicaltrials.gov, NCT05336916, registered on April 20th, 2022. https://clinicaltrials.gov/ct2/show/NCT05336916 .

Cross-sectional study examining psychometric properties of the Slovenian version of the 14-item Resilience Scale (RS-14-SL).

PURPOSE: Resilience has become an important concept in health research, addressing mental health outcomes. The purpose of this study was to translate, adapt, and evaluate psychometric properties of the Slovenian version of the 14-item Resilience Scale (RS-14), using a sample of general population and cancer survivors. METHODS: The original version of the RS-14 was first back-translated and pilot tested. The factor structure was assessed with an exploratory analysis and confirmed with a confirmatory analysis. To assess reliability, internal consistency (Cronbach's alpha) and test-retest (ICC, t student test) were determined. Measurement validity was assessed with demographic (age and gender) and psychological characteristics (symptoms of anxiety and depression and health-related quality of life). RESULTS: An exploratory factor analysis revealed one-factor solution in both samples and the fit indexes showed an acceptable model fit. Internal consistency showed excellent values (0.91-0.96), and test-retest reliability was found to be acceptable (ICC = 0.89). Significant correlations were found between RS-14 and anxiety and depression HADS subscales in Sample 1 (r = - 0.62, - 0.72 for anxiety and depression) and Sample 2 (r = - 0.43, r = - 0.51 for anxiety and depression) and the majority of EQ-5D subscales (usual activities, pain, anxiety/depression). CONCLUSION: The study showed that the Slovenian version of the RS-14 test scores is valid and stable. TRIAL REGISTRATION NUMBER: 0120-25/2019/6.

Barriers and facilitators for implementation of the SWORD evidence-based psychological intervention for fear of cancer recurrence in three different healthcare settings.

PURPOSE: Fear of cancer recurrence (FCR) interventions are effective, but few are implemented. This study aimed to identify barriers and facilitators for implementing the evidence-based blended SWORD intervention in routine psycho-oncological care. METHODS: Semi-structured interviews with 19 cancer survivors and 18 professionals from three healthcare settings assessed barriers and facilitators in six domains as described by the determinant frameworks of Grol and Flottorp: (1) innovation, (2) professionals, (3) patients, (4) social context, (5) organization, and (6) economic and political context. RESULTS: In the innovation domain, there were few barriers. Facilitators included high reliability, accessibility, and relevance of SWORD. In the professional domain, physicians and nurses barriers were lack of self-efficacy, knowledge, and skills to address FCR whereas psychologists had sufficient knowledge and skills, but some were critical towards protocolized treatments, cognitive behavioral therapy, or eHealth. Patient domain barriers included lack of FCR awareness, negative expectations of psychotherapy, and unwillingness/inability to actively engage in treatment. A social context domain barrier was poor communication between different healthcare professionals. Organization domain barriers included inadequate referral structures to psychological services, limited capacity, and complex legal procedures. Economic and political context domain barriers included lack of a national implementation structure for evidence-based psycho-oncological interventions and eHealth platform costs. CONCLUSIONS: Implementation strategies should be targeted at patient, professional, organizational and economic and political domains. Identified barriers and facilitators are relevant to other researchers in psycho-oncology that aim to bridge the research-practice gap. IMPLICATIONS FOR CANCER SURVIVORS: This study contributes to the implementation of evidence-based psychological interventions for cancer survivors, who can benefit from these services.

Evaluating the capacity of the distress thermometer to detect high fear of cancer recurrence.

OBJECTIVES: Fear of cancer recurrence (FCR) is common and burdensome to patients, but often remains undetected. Oncology professionals report need for tools to improve FCR detection in routine care. Oncology care guidelines recommend the Distress Thermometer (DT) for distress screening, but it has not been validated for FCR. This study evaluated the capacity of the DT and accompanying problem list to detect FCR. METHODS: Amalgamated data of two studies with 149 breast cancer and 74 colorectal cancer survivors were used. We evaluated the Dutch DT including the DT score, problem list fears item and emotional domain score using Receiver Operating Characteristic analyses. The Dutch Cancer Worry Scale-6 (CWS-6) was used as reference measure, with validated cut-off scores ≥10 and ≥12 for high FCR. Sensitivity, specificity, negative and positive predictive values were calculated. RESULTS: The DT score showed poor performance in discriminating between low and high FCR. The recommended cut-off ≥4 had low sensitivity (65% for CWS-6≥10; 72% for CWS-6 ≥12) and specificity (67% and 58%). No other cut-off had an acceptable combination of sensitivity and specificity. The fears item had low sensitivity (29% and 44.9%) and high specificity (95% and 94%). The emotional domain score had fair performance in discriminating between low and high FCR but there was no cut-off with acceptable sensitivity and specificity. CONCLUSION: The DT as currently recommended in oncology care guidelines is not suitable to effectively detect FCR in routine care. To improve patients access to psychosocial care, it should be investigated how FCR-specific measures can be integrated in oncology practice.

Health-related quality of life, psychological distress, and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 therapy.

BACKGROUND: Radium-223 is a registered treatment option for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). Aim of this multicenter, prospective observational cohort study was to evaluate health-related quality of life (HR-QoL), psychological distress and fatigue in mCRPC patients treated with radium-223. METHODS: Primary endpoint was cancer-specific and bone metastases-related HR-QoL, as measured by the EORTC QLQ-C30 and BM-22 questionnaires. Secondary endpoints were psychological distress and fatigue, evaluated by the HADS and CIS-Fatigue questionnaires. Outcomes were analyzed for the total cohort and between subgroups (1-3 versus 4-5 versus 6 radium-223 injections). A trajectory analysis was performed to explore HR-QoL patterns over time. RESULTS: In total, 122 patients were included for analysis. Baseline HR-QoL, pain intensity, psychological distress and fatigue were worse in patients who did not complete radium-223 therapy. In patients who completed therapy, stabilization of HR-QoL was perceived and psychological distress and fatigue remained stable, whereas clinically meaningful and statistically significant deterioration of HR-QoL, psychological distress and fatigue over time was observed in patients who discontinued radium-223 therapy. Trajectory analysis revealed that HR-QoL deterioration over time was more likely in patients with baseline opioid use, low hemoglobin and high alkaline phosphatase levels. CONCLUSIONS: Patients who discontinued radium-223 therapy showed worse HR-QoL, psychological distress and fatigue at baseline and more frequent deterioration of HR-QoL, psychological distress and fatigue over time when compared to patients who completed therapy. Specific attention with regard to HR-QoL during follow-up is indicated in patients with opioid use, low hemoglobin and high alkaline phosphatase levels before radium-223 therapy initiation. CLINICAL TRIAL REGISTRATION NUMBER: NCT04995614.

Systematic adaptation of the adherence improving self-management strategy to support breast cancer survivors' adherence to adjuvant endocrine therapy: An intervention mapping approach.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) for breast cancer leads to increased recurrence and mortality risk and healthcare costs. Evidence on feasible, effective AET adherence interventions is scarce. This paper describes the systematic adaptation of the cost-effective adherence improving self-management strategy (AIMS) for patients with HIV to AET for women after breast cancer treatment. METHODS: We followed the intervention mapping protocol for adapting interventions by conducting a needs assessment, reviewing target behaviours and determinants, reassessing behaviour change methods and adapting programme content. Therefore, we performed a literature review, consulted behavioural theory and organised nine advisory board meetings with patients and healthcare professionals. RESULTS: Non-adherence occurs frequently among AET users. Compared to HIV treatment, AET is less effective, and AET side effects are more burdensome. This drives AET treatment discontinuation. However, the key determinants of non-adherence are largely similar to HIV treatment (e.g. motivation, self-regulation and patient-provider relationship); therefore, most strategies in AIMS-HIV also seem suitable for AIMS-AET. Modifications were required, however, regarding supporting patients with coping with side effects and sustaining treatment motivation. CONCLUSION: AIMS seems to be a suitable framework for adherence self-management across conditions and treatments. Intervention mapping offered a transparent, systematic approach to adapting AIMS-HIV to AET.

Factors associated with a high level of unmet needs and their prevalence in the breast cancer survivors 1-5 years after post local treatment and (neo)adjuvant chemotherapy during the COVID-19: A cross-sectional study.

Objective: To assess the prevalence of unmet needs in post-treatment breast cancer survivors and identify sociodemographic, clinical, and psychosocial variables associated with reported unmet needs during the COVID-19 pandemic. Materials and methods: In this cross-sectional study, 430 post-treatment breast cancer survivors, ranging between 1 and 5 years after the procedure, completed the Cancer Survivors' Unmet Needs (CaSUN) questionnaire from September 2021 and January 2022. The multivariate logistic analysis identified factors associated with at least one reported unmet need in the total CaSUN scale and specific domains. Results: A total of 67% of survivors reported at least one unmet need. The most frequently reported unmet needs were the lack of accessible hospital parking (43%) and recurrence concerns (39.5%). The majority of reported unmet needs relate to comprehensive care (44%), followed by the psychological and emotional support domain (35.3%). Younger age (OR = 0.95, 95% CI = 0.92-0.99; p < 0.001), three or more comorbidities (OR = 0.27, 95% CI = 0.11-0.71, p < 0.01), a lower quality of life (OR = 0.06, 95% CI = 0.01-0.47, p < 0.01) and low resilience (OR = 0.95, 95% CI = 0.93-0.99) were associated with a high level of unmet needs in the multivariate regression model. Results are presented for factors associated with a high level of unmet needs for comprehensive cancer care and psychological and emotional support domain. Conclusion: A high prevalence found in our study could be attributed to the COVID-19 pandemic, where patients may have missed adequate follow-up care, although comparing to studies done in non-pandemic time is difficult. Family physicians should be more attentive toward younger cancer survivors and those with more comorbidities as both characteristics can be easily recognized in the family practice.

Psychosocial Aspects of Living Long Term with Advanced Cancer and Ongoing Systemic Treatment: A Scoping Review.

(1) Background: Studies examining the psychosocial impact of living long term on systemic treatment in advanced cancer patients are scarce. This scoping review aimed to answer the research question "What has been reported about psychosocial factors among patients living with advanced cancer receiving life-long systemic treatment?", by synthesizing psychosocial data, and evaluating the terminology used to address these patients; (2) Methods: This scoping review was conducted following the five stages of the framework of Arksey and O'Malley (2005); (3) Results: 141 articles published between 2000 and 2021 (69% after 2015) were included. A large variety of terms referring to the patient group was observed. Synthesizing qualitative studies identified ongoing uncertainty, anxiety and fear of disease progression or death, hope in treatment results and new treatment options, loss in several aspects of life, and worries about the impact of disease on loved ones and changes in social life to be prominent psychosocial themes. Of 82 quantitative studies included in the review, 76% examined quality of life, 46% fear of disease progression or death, 26% distress or depression, and 4% hope, while few studies reported on adaptation or cognitive aspects. No quantitative studies focused on uncertainty, loss, or social impact; (4) Conclusion and clinical implications: Prominent psychosocial themes reported in qualitative studies were not included in quantitative research using specific validated questionnaires. More robust studies using quantitative research designs should be conducted to further understand these psychological constructs. Furthermore, the diversity of terminology found in the literature calls for a uniform definition to better address this specific patient group in research and in practice.

Psychometric properties of the Slovenian version of the Cancer Survivors' Unmet Needs (CaSUN-SL) measure in post-treatment cancer survivors.

BACKGROUND: As the number of cancer survivors is growing, valid instruments for assessing cancer survivors' needs are required. Thus, the aim of this study was to translate and validate the Cancer Survivors Unmet Needs (CaSUN) scale. METHODS: Cancer survivors were recruited from 30 family medicine practices and separated into two samples (sample 1, n = 147; sample 2, n = 148). Factor structure was explored with an exploratory analysis in sample 1 and determined with a confirmatory analysis in sample 2. Psychometric properties were assessed with internal consistency, test-retest reliability and construct validity. RESULTS: A translation and cultural adaptation of the CaSUN scale resulted in 34 items being included in the final version. The factor structure confirmed the five-factors solution of the CaSUN-SL. Cronbach's alpha was 0.94 for the CaSUN-SL and ranged from 0.71-0.88 for specific domains. Test-retest reliability showed moderate-high stability over time. The CaSUN-SL significantly and positively correlated with anxiety (r = 0.49), depression (r = 0.44), health-related quality of life (r = 0.36), and negatively with self-perceived health (r = - 0.36) and resilience (r = - 0.47), which confirms the construct validity. In addition, we found a significant correlation between unmet needs and age (r = - 0.29), gender (r = 0.14), cancer stage (r = 0.20), cancer type (r = 0.19), and time since treatment (r = - 0.20). CONCLUSIONS: Results indicate that CaSUN-SL is a valid and reliable measure to assess the Slovenian cancer survivors' unmet, met and total needs and can be used for further prospective studies. TRIAL REGISTRATION: No. 0120-25/2019/6.

Interventions addressing fear of cancer recurrence: challenges and future perspectives.

PURPOSE OF REVIEW: Fear of cancer recurrence (FCR) is a common concern among cancer survivors and support for FCR is one of the most cited unmet needs. High FCR was found to be related to increased use of healthcare services, specifically primary healthcare and medical consultations, and lower quality of life. In the past decade screening instruments for FCR and interventions have been developed and proven effective. RECENT FINDINGS: Systematic reviews and meta-analyses have shown that psychological treatments are effective for reducing FCR. The cost-effectiveness of FCR interventions could be increased by considering stepped or matched models for supportive care. Despite availability of evidence-based interventions, the proposed care models are not implemented and most cancer survivors still do not benefit from supportive care. SUMMARY: The time is right to focus on implementation of FCR interventions into clinical practice. The complexity of optimizing FCR care is characterized by barriers and facilitators in the domains of patients, healthcare professionals, healthcare organizations and the broader economic, and political context. The main challenge for future research is to address these issues so that former investments in high-quality FCR intervention research will pay out in actual practice changes in the benefit of cancer survivors.