Short-term Changes in Health-related Quality of Life of Patients Undergoing Radical Surgery for Upper Urinary Tract Urothelial Carcinoma: Results from a Prospective Phase 2 Clinical Trial.

Background and objective: The possible negative impact of radical surgery on patients' health-related quality of life (HRQoL) plays an important role in preoperative counseling. Here, we analyzed the HRQoL of patients treated for upper urinary tract urothelial carcinoma (UTUC) in the context of a single-arm phase 2 multicenter study, in which the safety and efficacy of a single preoperative intravesical instillation with mitomycin C were investigated. Our objective was to investigate early changes in HRQoL in patients undergoing radical surgery for UTUC and identify factors associated with these outcomes. Methods: Patients with pTanyN0-1M0 UTUC were prospectively included. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire at baseline, and at 1 and 3 mo after surgery. A linear mixed model was used to evaluate the changes in HRQoL over time and identify the variables associated with these outcomes. The clinical effect size was used to assess the clinical impact and level of perceptibility of HRQoL changes for clinicians and/or patients based on given thresholds. Key findings and limitations: Between 2017 and 2020, 186 patients were included. At baseline, 1 mo after surgery, and 3 mo after surgery, response rates were 91%, 84%, and 78%, respectively. One month after surgery, a statistically significant and clinically relevant deterioration was observed in physical, role, and social functioning, and for the included symptom scales: constipation, fatigue, and pain. An improvement in emotional functioning was observed. At 3 mo, HRQoL returned to baseline levels, except emotional functioning, which improved at 1 mo and persisted to be better than that before surgery. Age >70 yr was associated with worse physical functioning, but better social and emotional functioning. Male patients reported better emotional functioning than females. Postoperative complications were negatively associated with social functioning. Conclusions and clinical implications: UTUC patients treated with radical surgery experienced a significant, albeit temporary, decline in HRQoL. Three months following surgery, HRQoL outcomes returned to baseline levels. This information can be used to counsel UTUC patients before undergoing radical surgery and contextualize recovery after surgery. Patient summary: We investigated the changes in quality of life as reported by patients who underwent surgery for upper tract urothelial carcinoma (UTUC). We found that patients experienced a decline in quality of life 1 mo after surgery, but this was temporary, with full recovery of quality of life 3 mo after surgery. These findings can help doctors and other medical staff in counseling UTUC patients before undergoing radical surgery.

[Treatment for an adjustment disorder after cancer: results of a Dutch study]. / Behandeling van een aanpassingsstoornis na kanker.

OBJECTIVE: To determine the effectiveness of treatment for an adjustment disorder in accordance with the Dutch guideline for an adjustment disorder in cancer survivor (i.e. people living with or after cancer) on distress, psychological symptoms and quality of life. DESIGN: Prospective cohort in which cancer survivors completed questionnaires prior to and after they received treatment for an adjustment disorder in accordance with the Dutch guideline 'adjustment disorder in patients with cancer'. METHOD: Using paired t-tests, the primary outcomes 'experienced distress' (Distress Thermometer) and 'psychological distress' (HADS) and secondary outcomes functioning, fatigue, and insomnia (EORTC-QLQ-C30) were compared before and after treatment. Clinically relevant improvement was also calculated for each outcome measure. The average costs per treatment were calculated based on the average number of sessions and the indexed NZA rate for the GGZ. RESULTS: A total of 563 cancer survivors received treatment and completed pre- and post-treatment questionnaires. They attended, on average, 11 treatment sessions. The average cost per treatment was €1.141. The results show a statistically significant decrease (p < .001) and a clinically relevant reduction in experienced distress, psychological distress, fatigue, insomnia and a clinically relevant improvement in functioning in cancer survivors following treatment for an adjustment disorder. CONCLUSION: Treatment for adjustment disorder for cancer survivors seems to lead to, at manageable cost, improved quality of life. Inclusion of the guideline in the quality register of the Dutch National Health Care Institute and treatment in accordance with this guideline is recommended.

Internet-based cognitive behavioral therapy aimed at alleviating treatment-induced menopausal symptoms in breast cancer survivors: Moderators and mediators of treatment effects.

OBJECTIVES: Results from our recently conducted randomized controlled trial (RCT) indicated that Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, is effective in reducing the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms in breast cancer survivors with treatment-induced menopausal symptoms. STUDY DESIGN: We used data of 235 women and compared the iCBT groups combined (n = 156) with the control group (n = 79). Bootstrapped multiple regression analyses with interaction terms (group x potential moderator) or indirect effects (mediation pathway) were conducted. MAIN OUTCOME MEASURES: Reductions in perceived impact of HF/NS and overall levels of menopausal symptoms. RESULTS: Women with lower levels of education benefited most from the iCBT. Age, time since diagnosis, current endocrine treatment, oophorectomy, frequency of HF/NS, and psychological distress did not moderate the treatment effects. Factors that mediated treatment effects were the development of healthier beliefs about experiencing hot flushes in a social context, about the impact of night sweats on sleep and daily functioning, and about the ability to control and cope with hot flushes. The acquisition of behavioral coping strategies and decreased psychological distress did not mediate treatment effects. CONCLUSION: The results suggest that women with lower levels of education may benefit most from the current iCBT program, with or without therapist support. The development of healthier HF/NS beliefs contribute significantly to the observed positive effect of iCBT on the burden of menopausal symptoms. CLINICAL TRIAL INFORMATION: NCT02672189.

Cost-utility, cost-effectiveness, and budget impact of Internet-based cognitive behavioral therapy for breast cancer survivors with treatment-induced menopausal symptoms.

PURPOSE: Internet-based cognitive behavioral therapy (iCBT), with and without therapist support, is effective in reducing treatment-induced menopausal symptoms and perceived impact of hot flushes and night sweats (HF/NS) in breast cancer survivors. The aim of the current study was to evaluate the cost-utility, cost-effectiveness, and budget impact of both iCBT formats compared to a waiting list control group from the Dutch healthcare perspective. METHODS: A Markov model was constructed with a 5-year time horizon. Costs and health outcomes were measured alongside a randomized controlled clinical trial and included quality-adjusted life years (QALYs), overall levels of menopausal symptoms, and perceived impact of HF/NS. Uncertainty was examined using probabilistic and deterministic sensitivity analyses, together with a scenario analysis incorporating a different perspective. RESULTS: iCBT was slightly more expensive than the waiting list control, but also more effective, resulting in incremental cost-utility ratios of €23,331/QALY and €11,277/QALY for the guided and self-managed formats, respectively. A significant reduction in overall levels of menopausal symptoms or perceived impact of HF/NS resulted in incremental costs between €1460 and €1525 for the guided and €500-€753 for the self-managed format. The estimated annual budget impact for the Netherlands was €192,990 for the guided and €74,592 for the self-managed format. CONCLUSION: Based on the current trial data, the results indicate that both guided and self-managed iCBT are cost-effective with a willingness-to-pay threshold of well below €30,000/QALY. Additionally, self-managed iCBT is the most cost-effective strategy and has a lower impact on healthcare budgets.

Efficacy of Internet-Based Cognitive Behavioral Therapy for Treatment-Induced Menopausal Symptoms in Breast Cancer Survivors: Results of a Randomized Controlled Trial.

PURPOSE: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms. PATIENTS AND METHODS: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large. RESULTS: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency. CONCLUSION: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.

An Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors: results of a pilot study.

OBJECTIVE: Previous studies demonstrated that a cognitive behavioral therapy (CBT) program delivered in group sessions is effective in alleviating treatment-induced menopausal symptoms in women with breast cancer, but also that in-person CBT is inconvenient for some women and can result in low levels of program compliance. A promising, alternative approach is to use the Internet to make this form of CBT more accessible and feasible for patients. The objective of this study was to evaluate the feasibility and to generate preliminary data on the efficacy of a guided, Internet-based CBT program. METHODS: Twenty-one participants with treatment-induced menopausal symptoms started the guided Internet-based CBT program. Self-report questionnaires were completed at baseline and at 10 weeks (posttreatment). Counselors' evaluations were obtained via interviews. Primary outcomes were program usage, compliance rates, and participant and counselor satisfaction. Secondary outcomes were overall levels of endocrine symptoms and hot flush/night sweats problem rating. RESULTS: Ninety percent of participants completed the program as planned. Satisfaction rates were high among participants and counselors. Small revisions to the program were advised. There was a significant decrease over time in overall levels of endocrine symptoms and hot flush/night sweats problem rating. CONCLUSIONS: These findings suggest that an Internet-based CBT program for women with treatment-induced menopausal symptoms is feasible and promising in terms of efficacy. The efficacy of the CBT program is currently being investigated in a larger randomized controlled trial.

Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors.

BACKGROUND: Menopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms. METHODS/DESIGN: In a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) post-randomization. DISCUSSION: Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause. TRIAL REGISTRATION: The study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).

Guided online self-management interventions in primary care: a survey on use, facilitators, and barriers.

BACKGROUND: Guided online psychological self-management interventions offer broad prospects for the treatment of people with mild to moderate mental health problems, but implementation is challenging. The aims of this study are (1) to gain insight into use of and intention to use these interventions among primary care health professionals, (2) to determine the main barriers to use such interventions among non-users. METHODS: An online survey based on the Unified Theory of Acceptance and Use of Technology (UTAUT) was disseminated among mental health counsellors (MHCs; in Dutch POHs) in GP practices and primary care psychologists (PCP) in mental health care practices. The survey covered the current use of online interventions, the intention to use these in the future, and an operationalization of the UTAUT concepts: performance expectancy, effort expectancy, social influence, and facilitating conditions. RESULTS: In total, 481 MHCs and 290 PCPs responded (24%). Of them, 49% of MHCs and 21% of PCPs currently use online interventions in their treatments. A further 40% of MHCs and 27% of PCPs plan to introduce such interventions within the next year. Both groups were moderately positive about the presence of eHealth facilitators in their daily practice. Among current non-users, performance expectancy and facilitating conditions were significant predictors of usage intention in both groups of health professionals. CONCLUSIONS: Use of and intention to use online interventions is relatively high in Dutch primary care. Non-users, particularly, experience several barriers which need attention to enhance implementation. There is a need for further efforts regarding facilitation of and education on eHealth, as well as for research directed to its normalization in daily practice.

Implementation of The World Starts With Me, a comprehensive rights-based sex education programme in Uganda.

This article presents a process evaluation of the implementation of the sex education programme the World Starts With Me (WSWM) for secondary school students in Uganda. The purpose of this mixed-methods study was to examine factors associated with dose delivered (number of lessons implemented) and fidelity of implementation (implementation according to the manual), as well as to identify the main barriers and facilitators of implementation. Teachers' confidence in teaching WSWM was negatively associated with dose delivered. Confidence in educating and discussing sexuality issues in class was positively associated with fidelity of implementation, whereas the importance teachers attached to open sex education showed a negative association with fidelity. Main barriers for implementing WSWM were lack of time, unavailability of computers, lack of student manuals and lack of financial support and rewards. Other barriers for successful implementation were related to high turnover of staff and insufficient training and guidance of teachers. Teachers' beliefs/attitudes towards sexuality of adolescents, condom use and sex education were found to be important socio-cognitive factors intervening with full fidelity of implementation. These findings can be used to improve the intervention implementation and to better plan for large-scale dissemination of school-based sex education programmes in sub-Saharan Africa.