Trials (Jan 2022)
Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol
Abstract
Abstract Background Men with localized prostate cancer often experience urinary, sexual, bowel, and hormonal symptoms; general distress; pain; fatigue; and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couples’ relationships and intimacy. The symptoms also reduce quality of life for both men and their partners, who are often their primary caregivers. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. To address these unmet supportive care needs, our interdisciplinary team developed and pilot tested the usability and feasibility of an evidence-based, couple-focused, tailored eHealth intervention, “Prostate Cancer Education & Resources for Couples” (PERC). Based on the adapted stress and coping theoretical framework and developed with stakeholder involvement, PERC aims to improve quality of life for both men and their partners by enhancing their positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management. Methods We will test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. Primary aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related quality of life scores than those in the control group (usual care plus the National Cancer Institute prostate cancer website) at 4, 8, and 12 months post-baseline. Secondary aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group. Exploratory aim: Determine if patient race and ethnicity, education, type of treatment, or couples’ relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups. Discussion This study will provide a novel model for self-managing chronic illness symptoms that impact couples’ relationships, intimacy, and quality of life. It addresses the National Institute of Nursing Research’s goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve quality of life. It also responds to calls for programs from the Institute of Medicine and American Cancer Society to address treatment-related effects and improve survivors’ QOL. Trial registration CT.gov NCT03489057
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