Evaluating a Tailored Web-Based eHealth Intervention for Symptom Management in Couples Managing Prostate Cancer During the COVID-19 Pandemic: Randomized Clinical Trial.

Background: Prostate cancer (PCa) is the most common nonskin cancer among men. Although treatments achieve excellent survival for localized PCa, long-lasting complications significantly diminish patients' quality of life (QOL) across physical, sexual, psychosocial, and general symptom domains. Because these effects also profoundly impact intimate partners, often reducing partners' QOL as much as or more than patients' QOL, supportive care must address the needs of both members of the couple. Objective: This study evaluated the efficacy of the Prostate Cancer Education and Resources for Couples (PERC) eHealth intervention in improving outcomes for patients and their partners. Methods: We enrolled 280 dyads (560 individuals) consisting of patients with localized PCa who recently completed treatment and their partners through the North Carolina Cancer Registry. Dyads were randomized to PERC or a control group that received access to the National Cancer Institute prostate cancer website. PERC dyads completed a nurse-led orientation and received monthly follow-ups. The platform has the following three components: (1) 11 interactive modules with postsession assignments on QOL, symptom management, and cancer communication; (2) a moderated online forum providing professional and peer support; and (3) a resource toolbox containing scientific publications related to PCa care. PERC development was guided by an adapted stress-coping theory and informed by evidence and stakeholder input. Validated questionnaires assessed QOL (Functional Assessment of Chronic Illness Therapy-General [FACT-G] total; primary outcomes), FACT-G subdomains, and symptom and psychosocial measures (secondary outcomes) at baseline and at 4, 8, and 12 months. Multilevel linear mixed models tested intervention effects. Results: The trial was conducted during the COVID-19 pandemic. Among PERC (n=141) and control (n=139) dyads who completed baseline assessments, 221 (78.9%) dyads completed the 12-month follow-up (PERC=106 and control=115). FACT-G total score, subdomains, and overall psychosocial outcomes did not differ significantly between groups over time. Patients assigned to PERC reported better physical QOL (mean difference 0.9, 95% CI -0.1 to 1.9; Cohen d=0.33), less negative illness appraisal (mean difference 0.2, 95% CI 0.0-0.4; Cohen d=0.38), lower pain (mean difference -2.7, 95% CI -5.3 to -0.2; Cohen d=-0.38) at 12 months, and less frequent fatigue across time (mean difference -2.1, -95% CI -3.9 to -0.4; Cohen d=-0.23). PERC partners reported less urinary symptom bother at 8 months (mean difference 6.5, 95% CI -1.0 to 14.1; Cohen d=0.44). Conclusions: Although no significant between-group difference was observed in the FACT-G total score, PERC demonstrated exploratory benefits, including improved physical QOL, less fatigue, lower pain, and improved illness appraisal among patients, as well as less urinary bother among partners. These findings suggest that the COVID-19 pandemic may have adversely affected participants' overall QOL, potentially obscuring changes in the primary outcome, while highlighting targeted benefits that warrant evaluation in larger studies.