Oncology · Medical Literature
Evaluating a Tailored Web-Based eHealth Intervention for Symptom Management in Couples Managing Prostate Cancer During the COVID-19 Pandemic: Randomized Clinical Trial.
Abstract
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. 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. 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. 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). 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.
Clinical relevance
Does the PERC (Prostate Cancer Education and Resources for Couples) tailored web-based eHealth intervention, compared with access to the NCI prostate cancer website, improve overall quality of life in patients with localized prostate cancer recently completing treatment and their intimate partners? __SNAPSHOT__ {"studyDesign":"Two-arm parallel-group randomized controlled trial (RCT)","setting":"Population-based; participants recruited through the North Carolina Cancer Registry (Rapid Case Ascertainment); multi-institutional research team spanning University of Texas at San Antonio, Northwestern University, University of North Carolina at Chapel Hill, and University of Michigan; trial conducted during the COVID-19 pandemic","sampleSize":"n=280 dyads (560 individuals) enrolled; 141 dyads randomized to PERC, 139 to control; 221 dyads (78.9%) completed 12-month follow-up (PERC=106, control=115)","population":"Patient-partner dyads: male patients aged 40–75 years with localized prostate cancer within 16 weeks of completing initial curative-intent treatment, enrolled with their intimate partners; recruited statewide across North Carolina for geographic and demographic diversity","intervention":"PERC eHealth platform comprising: (1) 11 interactive tailored modules with post-session assignments addressing QOL, symptom management, and cancer communication; (2) a moderated online forum providing professional and peer support; and (3) a resource toolbox of PCa-related scientific publications. Dyads also completed a nurse-led orientation and received monthly follow-ups. Theoretically grounded in an adapted stress-coping framework.","comparator":"Access to the National Cancer Institute (NCI) prostate cancer informational website (active control/usual care augmented with information)","primaryOutcome":"Health-related quality of life measured by the Functional Assessment of Chronic Illness Therapy–General (FACT-G) total score, assessed for both patients and partners at baseline and at 4, 8, and 12 months","followUp":"12 months (assessments at baseline [T1], 4 months [T2], 8 months [T3], and 12 months [T4])","fundingSource":"Government (National Institutes of Health / National Institute of Nursing Research, R01NR016990, PI: Song); no conflicts of interest declared"}
Key findings
The primary outcome — FACT-G total score — did not differ significantly between the PERC and control groups over the 12-month follow-up period; FACT-G subdomains and overall psychosocial outcomes were also non-significant between groups. In prespecified exploratory (secondary) analyses, patients assigned to PERC reported marginally 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), and lower pain (mean difference −2.7, 95% CI −5.3 to −0.2; Cohen d=0.38). PERC partners reported less urinary symptom bother at the 8-month timepoint (T3; 95% CI −1.0 to 14.1; Cohen d=0.44). Less fatigue among PERC patients was also reported as an exploratory benefit, though specific numerical data were not available in the abstract. Effect sizes for exploratory benefits were small-to-moderate (Cohen d=0.33–0.44). P-values for individual secondary outcomes were not reported in the abstract. NNT is not calculable from available data. No adverse event data were reported. All noted benefits should be considered exploratory given the non-significant primary endpoint.
Practice implications
This trial did not establish efficacy of the PERC eHealth intervention on its pre-specified primary endpoint of overall QOL (FACT-G total score) among prostate cancer patient-partner dyads. The failure to detect a primary outcome effect may be attributable, at least in part, to the disruptive context of the COVID-19 pandemic, which the authors hypothesize may have broadly suppressed QOL in both arms, attenuating the detectable intervention signal. The exploratory findings — improved physical QOL, lower pain, less fatigue, and better illness appraisal in patients, plus reduced urinary bother in partners — are hypothesis-generating but cannot be interpreted as confirmatory evidence of efficacy given that the primary endpoint was not met. These findings apply specifically to men aged 40–75 with localized PCa within 16 weeks of completing curative-intent treatment who are in an intimate relationship. Non-partnered patients, those with advanced disease, and those who have completed treatment more remotely were not studied. Same-sex couples and racial/ethnic subgroups may be underrepresented; the protocol identified race/ethnicity and treatment type as exploratory moderators, but results for these subgroups are not reported in the abstract. Practice should not change based on this trial alone; the intervention may still hold promise but requires replication in a pandemic-free environment with a larger, adequately powered sample. Only the abstract was available for this summary; full-text review is warranted before clinical synthesis. __LIMITATIONS__ Primary endpoint (FACT-G total score) was not met, rendering all secondary and exploratory findings as hypothesis-generating only.,The trial was conducted entirely during the COVID-19 pandemic, a major contextual confounder that may have uniformly suppressed QOL in both arms, reducing power to detect between-group differences.,Attrition: 21.1% of dyads did not complete 12-month follow-up (PERC=106/141 [75.2%], control=115/139 [82.7%]), with differential retention potentially introducing bias.,Active control (NCI website) may itself provide meaningful informational support, potentially underestimating PERC's true effect vs. true usual care.,Multiple secondary and exploratory outcomes tested without explicit correction for type I error inflation, increasing risk of false-positive findings.,Effect sizes for exploratory benefits are small-to-moderate (Cohen d=0.33–0.44); clinical meaningfulness of these differences is uncertain.,Sample restricted to North Carolina via cancer registry; generalizability to other geographic regions, healthcare systems, and racial/ethnic populations is unclear.,Outcomes based entirely on self-report; no objective or clinical endpoints included.,Partner QOL outcomes were secondary; the trial was not independently powered for partner-level efficacy.,Only the abstract was available for full methodological appraisal, including randomization procedures, allocation concealment, blinding strategies, and protocol deviations. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ The PERC tailored eHealth intervention did not significantly improve overall QOL (FACT-G total score) compared to NCI website access in localized prostate cancer patient-partner dyads over 12 months, with the COVID-19 pandemic identified as a potential confounding context. Exploratory signals of benefit in physical QOL, pain, fatigue, and illness appraisal (patients) and urinary bother (partners) are intriguing but not confirmatory, and should not alter clinical practice. Larger trials in non-pandemic conditions are needed before this type of dyadic eHealth intervention can be recommended as standard supportive care.