Impact of a nurse-led and a web-based psychoeducational program for advanced cancer patients and their caregivers: Results of a three-arm randomized controlled trial.

BACKGROUND

Advanced cancer impacts the lives of both patients and their family caregivers. They often experience substantial declines in quality of life and physical, emotional, and spiritual distress that generate significant unmet psychosocial care needs. These effects are interrelated. Dyadic psychoeducational interventions, helping dyads to manage the impact of the disease and maintain their quality of life, demonstrate benefits by concurrently addressing challenges for oncology patients and family caregivers. The aim of this study was to evaluate the effects of a face-to-face nurse-led and a web-based psychoeducational intervention for patients with advanced cancer and their family caregivers on primary (emotional function and self-efficacy) and secondary endpoints.

METHODS

This international multicenter three-arm parallel-group superiority randomized controlled trial was conducted in 6 European countries (Belgium, Denmark, Italy, Netherlands, Ireland and UK). Between February 2021 and August 2023, dyads formed by patients with advanced solid cancer and their primary family caregiver were randomly assigned without blinding to a face-to-face psychoeducational intervention, a web-based psychoeducational intervention, or standard care. The two primary endpoints were 1) emotional functioning (10-item European Organization for Research and Treatment of Cancer short form), and 2) self-efficacy (Cancer Self-efficacy Scale) for patients with advanced cancer and their family caregivers at 12 weeks. Secondary outcomes included quality of life, benefits of illness appraisal, coping, and dyad communication at 12 weeks and 24 weeks.

RESULTS

In total, 431 dyads were randomized to the face-to-face group (n=140), the web-based group (n=148) or standard care (n=143). Neither the face-to-face group nor the web-based group showed significant improvements compared to control group in emotional functioning for patients (-0.27; 95%CI -2.11 to 0.76 and.12; 95 % CI -1.65 to 1.89) or caregivers (30; 95 % CI -1·41 to 2·00 and 0.17; 95 % CI -1.45 to 1.79); a significant improvement of patients' self-efficacy (9.02; 95 % CI 2.45 to 15.58) in the face-to-face group was found. Further analysis indicated a positive effect at 12 weeks for the face-to-face group on patients' dyadic coping and ways of giving support, and on caregivers' problem-focused coping. There were no significant effects for the web-based group.

CONCLUSION

Our trial showed neutral findings for emotional function in both a face-to-face nurse-led and a web-based psychoeducational dyadic support program. Positive findings were found for patients' self-efficacy and several secondary outcomes in patients and caregivers for the face-to-face program. Why the face-to-face but not the web-based program led to positive findings for several outcomes needs further evaluation.

TRIAL REGISTRATION: Clinicaltrial.gov (NCT04626349). The trial is now closed.