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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. 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. 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). 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. Dutch Cancer Society (KWF Kankerbestrijding).

During interpersonal emotion regulation, relationship partners mutually regulate each other’s emotional states. Interpersonal emotion regulation occurs at three main timescales: phasic (from several hundred milliseconds to about 10s), tonic (from 10s to 1 hour), and chronic (from weeks to months and years). Prior research has examined interpersonal emotion regulation at only one or two timescales simultaneously. The proposed research will examine variables relating to interpersonal emotion regulation in close relationships across all three timescales. A total of 150 romantic couples will engage in an emotional sharing task, in which they will be instructed to either engage in natural sharing or co-rumination. At the phasic timescale, primary outcomes will be interpersonal synchrony in movements and cardiovascular responses throughout the sharing task. At the tonic timescale, primary outcomes will be changes in mood and emotional appraisals pre- and post-sharing. At the chronic timescale, the study will primarily assess individual differences in relationship quality and dyadic coping style prior to the task, which are expected to shape phasic and tonic patterns during emotional sharing. Our general expectation is that phasic patterns in interpersonal emotion regulation (e.g., movement synchrony) will be meaningfully related to tonic patterns (e.g., mood change), which, in turn, will be meaningfully related to chronic patterns (e.g., relationship quality). More differentiated hypotheses and exploratory analyses are detailed in the protocol. The results of this research will contribute to the integration of interpersonal emotion regulation theories across different time scales.

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.

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 aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU). A total of 170 cancer survivors were randomly assigned to one of the three study arms: MCGP-CS (n = 57); SGP (n = 56); CAU (n = 57). The primary outcome measure was the Personal Meaning Profile (PMP; total score). Secondary outcome measures were subscales of the PMP, psychological well-being (Scales of Psychological Well-being; SPWB), post-traumatic growth (Posttraumatic Growth Inventory), Mental Adjustment to Cancer (MAC), optimism (Life Orientation Test-Revised), hopelessness (Beck's Hopelessness Scale), psychological distress (anxiety and depression, Hospital Anxiety and Depression Scale; HADS) and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ-C30). Outcome measures were assessed before randomization, post-intervention, and after 3 and 6 months of follow-up (FU). Linear mixed model analyses (intention-to-treat) showed significant differences between MCGP-CS, SGP and CAU on the total PMP score, and on (sub)scales of the PMP, SPWB, MAC and HADS. Post-hoc analyses showed significantly stronger treatment effects of MCGP-CS compared with CAU on personal meaning (d = 0.81), goal-orientedness (d = 1.07), positive relations (d = 0.59), purpose in life (d = 0.69); fighting spirit (d = 0.61) (post-intervention) and helpless/hopeless (d = -0.87) (3 months FU); and distress (d = -0.6) and depression (d = -0.38) (6 months FU). Significantly stronger effects of MCGP-CS compared with SGP were found on personal growth (d = 0.57) (3 months FU) and environmental mastery (d = 0.66) (6 months FU). MCGP-CS is an effective intervention for cancer survivors to improve personal meaning, psychological well-being and mental adjustment to cancer in the short term, and to reduce psychological distress in the long run.

Purpose After meaning-centered group psychotherapy for cancer survivors (MCGP-CS), depressive symptoms tend to decrease. An enhanced sense of meaning may play a mediating role in this decrease. The aim of this study was to assess whether personal meaning mediates the relationship between MCGP-CS and depressive symptoms. Methods Cancer survivors ( n  = 114) were randomly allocated to MCGP-CS or care as usual (CAU). The assessments were scheduled at baseline, postintervention, and at 3- and 6-month follow-up. Mediation models were estimated based on structural equation modeling. We computed the indirect effect of MCGP-CS on depressive symptoms at the 3-month follow-up through personal meaning, and other meaning-related mediators, measured postintervention. Results A small but significant indirect effect of MCGP-CS on depressive symptoms at the 3-month follow-up was found through personal meaning postintervention ( b  = − 0.29, 95% bootstrap CI (− 0.63, − 0.03)). There were no significant indirect effects through the other meaning-related factors. Conclusions This study tentatively supports the MCGP-CS working model in that an enhanced sense of meaning as a result of MCGP-CS mediates a reduction in depressive symptoms. Personal meaning mediated a small effect of MCGP-CS on depressive symptoms. The longitudinal mediating effect of personal meaning occurred within a time period of 3 months after MCGP-CS. Relevance MCGP-CS is a psychological intervention that supports cancer survivors in regaining or enhancing a sense of meaning in their lives. This enhanced sense of meaning is a protective factor against depressive symptoms. Trial registration The RCT was registered in the Netherlands Trial Register (number NTR3571/NL3421) on August 10, 2012.

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/ ).

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