Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors

Background: Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) improves meaning, psychological well-being, and mental adjustment to cancer and reduces psychological distress. This randomized controlled trial was conducted to investigate the cost-utility of MCGP-CS compared with supportive group psychotherapy (SGP) and care-as-usual (CAU). Methods: In total, 170 patients were randomized to MCGP-CS, SGP, or CAU. Intervention costs, direct medical and nonmedical costs, productivity losses, and health-related quality of life were measured until 6 months follow-up, using the TIC-P, PRODISQ, data from the hospital information system, and the EQ-5D. The cost-utility was calculated by comparing mean cumulative costs and quality-adjusted life years (QALYs). Results: Mean total costs ranged from €4492 (MCGP-CS) to €5304 (CAU). Mean QALYs ranged.507 (CAU) to.540 (MCGP-CS). MCGP-CS had a probability of 74% to be both less costly and more effective than CAU, and 49% compared with SGP. Sensitivity analyses showed these findings are robust. If society is willing to pay €0 for one gained QALY, MCGP-CS has a 78% probability of being cost-effective compared with CAU. This increases to 85% and 92% at willingness-to-pay thresholds of €10 000 and €30 000, which are commonly accepted thresholds. Conclusions: MCGP-CS is highly likely a cost-effective intervention, meaning that there is a positive balance between the costs and gains of MCGP-CS, in comparison with SGP and CAU

Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors:a randomised, controlled trial

Background Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. Methods In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. Findings Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6−6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI −0·8–4·1], p=0·41). Interpretation Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors

The impact of cancer on psychosocial function and quality of life: A cross-sectional study in 18 pan-European countries

Background: To improve psychosocial cancer care in Europe, more information is needed on psychosocial function and quality of life (QoL) among cancer patients in European countries. Aims: To investigate differences in psychosocial function between cancer survivors and the general population in Europe, in relation to national economic status and personal factors. Method: Data were from the Survey of Health, Aging and Retirement in Europe (Wave 6). Main outcomes were psychosocial functioning: activity limitations, income adequacy, loneliness, depression, and QoL. Factors possibly associated with the main outcomes were ever having cancer, gross domestic product (GDP), and personal factors (age, gender, education, marriage status, employment status, number of children, number of chronic diseases). Results: The study sample featured 6238 cancer survivors and 60,961 individuals without cancer aged 50 or older in 17 European countries and Israel. Levels of depression were higher and QoL was lower among cancer survivors compared to individuals without cancer and worse in low GDP countries, whereas differences in income adequacy and loneliness were not statistically significant. The interaction of cancer groups and country groups indicated a significant interactional effect on activity limitations, loneliness, depression, and QoL. In a multivariate regression analysis, personal factors, GDP, and being a cancer survivor predicted the main outcome variables. Conclusions: Cancer has a persistent negative effect on survivors that is related to a country's GDP. Cancer survivors in low-GDP countries are affected by the consequences of cancer intertwined with the hardships of living in a low-GDP country

Long-term efficacy of meaning-centered group psychotherapy for cancer survivors: 2-Year follow-up results of a randomized controlled trial

Objective: Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) is an effective intervention to improve personal meaning, psychological well-being, and depressive symptoms until 6 months after the intervention. In this study, the long-term effects of MCGP-CS (i.e., at 1- and 2-year follow-up) on meaning, psychological well-being and posttraumatic growth were assessed, in comparison to supportive group psychotherapy (SGP) and care as usual (CAU). Methods: Cancer survivors (n = 170) were randomized into MCGP-CS, SGP, or CAU. Assessments were scheduled at baseline, 1 week, 3 months, 6 months, 1 year, and 2 years postintervention. Outcome measures were the Personal Meaning Profile, Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory, and their subscales. Linear mixed models (LMM) were used and results were both reported on an intention-to-treat (ITT) basis, as well as for intervention completers only. Results: LMM and post hoc analyses with Bonferroni correction revealed that MCGP-CS participants reported more improvement on positive relations (subscale of SPWB) than CAU participants of 2-year postintervention (ITT analysis, Cohen's d =.82). Completers also reported more personal growth (subscale of SPWB) after MCGP-CS than after SGP 1-year postintervention (Cohen's d =.94). No long-term effects were found on the other outcome measures. Conclusions: In the 2 years after MCGP-CS, the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded. However, MCGP-CS had a long-term positive effect on positive relations with others and on survivors' sense of personal growth. Trial registration: Netherlands Trial Register: NTR3571

Long‐term efficacy of meaning‐centered group psychotherapy for cancer survivors: 2‐Year follow‐up results of a randomized controlled trial

Objective: Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) is an effective intervention to improve personal meaning, psychological well-being, and depressive symptoms until 6 months after the intervention. In this study, the long-term effects of MCGP-CS (i.e., at 1- and 2-year follow-up) on meaning, psychological well-being and posttraumatic growth were assessed, in comparison to supportive group psychotherapy (SGP) and care as usual (CAU). Methods: Cancer survivors (n = 170) were randomized into MCGP-CS, SGP, or CAU. Assessments were scheduled at baseline, 1 week, 3 months, 6 months, 1 year, and 2 years postintervention. Outcome measures were the Personal Meaning Profile, Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory, and their subscales. Linear mixed models (LMM) were used and results were both reported on an intention-to-treat (ITT) basis, as well as for intervention completers only. Results: LMM and post hoc analyses with Bonferroni correction revealed that MCGP-CS participants reported more improvement on positive relations (subscale of SPWB) than CAU participants of 2-year postintervention (ITT analysis, Cohen's d =.82). Completers also reported more personal growth (subscale of SPWB) after MCGP-CS than after SGP 1-year postintervention (Cohen's d =.94). No long-term effects were found on the other outcome measures. Conclusions: In the 2 years after MCGP-CS, the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded. However, MCGP-CS had a long-term positive effect on positive relations with others and on survivors' sense of personal growth. Trial registration: Netherlands Trial Register: NTR3571

Moderators of the effects of meaning-centered group psychotherapy in cancer survivors on personal meaning, psychological well-being, and distress

PURPOSE: There is evidence to support that meaning-centered group psychotherapy for cancer survivors (MCGP-CS) is an effective intervention for improving personal meaning and psychological well-being, as well as reducing psychological distress. In order to investigate which subpopulations MCGP-CS specifically benefits, this explorative study aims to analyze potential sociodemographic, clinical, and psychosocial factors that may moderate the effects. METHODS: Cancer survivors (N = 114) were randomly assigned to MCGP-CS, or care as usual (CAU). Potential moderators included age, sex, relationship, education, employment, religion, cancer type, tumor stage, cancer treatment, time since treatment, anxiety, depression, other negative life events, and previous psychological treatment. Outcome measures were the Personal Meaning Profile (PMP), Scales of Psychological Well-Being (SPWB), and the Hospital Anxiety and Depression Scale (HADS). Assessment took place at baseline, post-intervention (short-term), and 3- and 6-month follow-ups (long-term). For each moderator, separate short-term and long-term linear mixed models were built. RESULTS: Short-term effect of MCGP-CS was moderated by (male) sex (on HADS-D; F(1,98) = 6.1, p = .015) and (a high level of) depressive symptoms at baseline (on SPWB; F(1,93) = 5.7, p = .019). Long-term effect of MCGP-CS was moderated by (not having received) previous psychological treatment (on HADS-total; F(3253) = 3.4, p = .017). CONCLUSIONS: Most sociodemographic and clinical characteristics do not appear to moderate the positive effect of MCGP-CS on personal meaning. However, MCGP-CS appears to reduce depressive symptoms, particularly in males, and to improve purpose in life of survivors with depressive symptoms. In the long-term, MCGP-CS appears to reduce psychological distress in survivors who had not received psychological treatment in the past year. TRIAL REGISTRATION: NTR3571

The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties

Introduction: The International Index of Erectile Function (IIEF) is a patient-reported outcome measure to evaluate erectile dysfunction and other sexual problems in men. Aim: To perform a systematic review of the measurement properties of the 15-item patient-reported outcome measure (IIEF-15) and the shortened 5-item version (IIEF-5). Methods: A systematic search of scientific literature up to April 2018 was performed. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines for structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence of measurement properties was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low. Results: 40 studies were included. The evidence for criterion validity (of the Erectile Function subscale), and responsiveness of the IIEF-15 was sufficient (high quality), but inconsistent (moderate quality) for structural validity, internal consistency, construct validity, and test-retest reliability. Evidence for structural validity, test-retest reliability, construct validity, and criterion validity of the IIEF-5 was sufficient (moderate quality) but indeterminate for internal consistency, measurement error, and responsiveness. Clinical Implications: Lack of evidence for and evidence not supporting some of the measurement properties of the IIEF-15 and IIEF-5 shows the importance of further research on the validity of these questionnaires in clinical research and clinical practice. Strengths & Limitations: A strength of the current review is the use of predefined guidelines (COSMIN). A limitation of this review is the use of a precise rather than a sensitive search filter regarding measurement properties to identify studies to be included. Conclusion: The IIEF requires more research on structural validity (IIEF-15), internal consistency (IIEF-15 and IIEF-5), construct validity (IIEF-15), measurement error (IIEF-15 and IIEF-5), and responsiveness (IIEF-5). The most pressing matter for future research is determining the unidimensionality of the IIEF-5 and the exact factor structure of the IIEF-15. Neijenhuijs KI, Holtmaat K, Aaronson NK, et al. The International Index of Erectile Function (IIEF)—A Systematic Review of Measurement Properties. J Sex Med 2019;16:1078–1091

Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs:A study protocol of a randomized controlled trial

Background: Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas. Methods: A total of 136 adult partners of patients with incurable cancer will be included. Partners will be randomly assigned to the intervention group, which directly gets access to Oncokompas, or the waiting-list control group, which gets access to Oncokompas after three months. The primary outcome measure is caregiver burden. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion: This study will result in evidence on the efficacy and cost-utility of Oncokompas among partners of patients with incurable cancer, which might lead to implementation of Oncokompas as a health service for partners of patients with incurable cancer

The Female Sexual Function Index (FSFI)—A Systematic Review of Measurement Properties

Introduction: The Female Sexual Function Index (FSFI) is a patient-reported outcome measure measuring female sexual dysfunction. The FSFI-19 was developed with 6 theoretical subscales in 2000. In 2010, a shortened version became available (FSFI-6). Aim: To investigate the measurement properties of the FSFI-19 and FSFI-6. Methods: A systematic search was performed of Embase, Medline, and Web of Science for studies that investigated measurement properties of the FSFI-19 or FSFI-6 up to April 2018. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low. Main Outcome Measures: The Main Outcome Measure is the evidence of a measurement property, and the quality of evidence based on the COSMIN guidelines. Results: 83 studies were included. Concerning the FSFI-19, the evidence for internal consistency was sufficient and of moderate quality. The evidence for reliability was sufficient but of low quality. The evidence for criterion validity was sufficient and of high quality. The evidence for structural validity was inconsistent of low quality. The evidence for construct validity was inconsistent of moderate quality. Concerning the FSFI-6, the evidence for criterion validity was sufficient of moderate quality. The evidence for internal consistency was rated as indeterminate. The evidence for reliability was inconsistent of low quality. The evidence for construct validity was inconsistent of very low quality. No information was available on structural validity of the FSFI-6, and measurement error, responsiveness, and cross-cultural validity of both FSFI-6 and FSFI-19. Clinical Implications: Conflicting and lack of evidence for some of the measurement properties of the FSFI-19 and FSFI-6 indicates the importance of further research on the validity of these patient-reported outcome measures. We advise researchers who use the FSFI-19 to perform confirmatory factor analyses and report the factor structure found in their sample. Regardless of these concerns, the FSFI-19 and FSFI-6 have strong criterion validity. Pragmatically, they are good screening tools for the current definition of female sexual dysfunction. Strength & Limitation: A strong point of the review is the use of predefined guidelines. A limitation is the use of a precise rather than a sensitive search filter. Conclusions: The FSFI requires more research on structural validity (FSFI-19 and FSFI-6), reliability (FSFI-6), construct validity (FSFI-19), measurement error (FSFI-19 and FSFI-6), and responsiveness (FSFI-19 and FSFI-6). Further corroboration of measurement invariance (both across cultures and across subpopulations) in the factor structure of the FSFI-19 is necessary, as well as tests for the unidimensionality of the FSFI-6. Neijenhuijs KI, Hooghiemstra N, Holtmaat K, et al. The Female Sexual Function Index (FSFI)—A Systematic Review of Measurement Properties. J Sex Med 2019;16:640–660

Reach and efficacy of the eHealth application Oncokompas, facilitating partners of incurably ill cancer patients to self-manage their caregiver needs: a randomized controlled trial

Purpose: Many partners of incurably ill cancer patients experience caregiver burden. The eHealth application “Oncokompas” supports these partners to manage their caregiver needs and to find optimal supportive care for themselves. The aim of this randomized controlled trial (RCT) was to investigate the reach of Oncokompas and its efficacy on caregiver burden, self-efficacy, and health-related quality of life (HRQOL). Methods: The reach was estimated based on eligibility, participation rate, and an evaluation of the recruitment process. Efficacy on caregiver burden was measured using the Caregiver Strain Index + (CSI +). Secondary outcomes were self-efficacy (General Self-Efficacy Scale (GSE)) and HRQOL (EQ-5D VAS). Assessments were scheduled at baseline, 2 weeks after randomization and 3 months after baseline. Linear mixed models were used to compare longitudinal changes between the experimental and control group from baseline to the 3-month follow-up. Results: The reach, in terms of eligibility and participation rate, was estimated at 83–91%. Partners were most likely reached via palliative care consultants, patient organizations, and palliative care networks. In the one-and-a-half-year recruitment period and via the 101 organizations involved, 58 partners were included. There were no significant effects of Oncokompas on caregiver burden, self-efficacy, or HRQOL. Conclusion: The reach of Oncokompas among interested individuals was high, but the difficulties that were encountered to include partners suggest that the reach in real life may be lower. This study showed no effect of Oncokompas on caregiver burden, self-efficacy, or HRQOL in partners of incurably ill cancer patients. Relevance: The results of this study may be used in the process of developing, efficacy testing, and implementing eHealth applications for caregivers of incurably ill cancer patients. Trial registration: Netherlands Trial Register identifier: NTR7636/NL7411. Registered on November 23, 2018 (https://www.trialregister.nl/)