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/ ).

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. TRIAL REGISTRATION: Netherlands Trial Register, NTR 7636. Registered on 23 November 2018.

Efficacy and cost-utility of the eHealth application 'Oncokompas', supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial.

BACKGROUND: Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative 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 compared to care as usual. METHODS: 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient's knowledge, skills and confidence to manage his or her own health and healthcare. 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 knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. TRIAL REGISTRATION: Netherlands Trial Register identifier: NTR 7494 . Registered on 24 September 2018.

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.