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
| Original language | English (US) |
|---|---|
| Article number | 12 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 2022 |
Funding
The University of North Carolina-Lineberger Comprehensive Cancer Center Cancer (UNC LCCC) Prevention and Control Intervention Research Pilot Grant Award (PI: Song) and UNC LCCC Population Sciences Developmental Research Award (PI: Song) have provided funding for the pilot testing of PERC. We would like to thank the prostate cancer patients, their families, healthcare professionals, and our research staff for their contributions in the pilot studies and our ongoing trial to make the study possible. LS is the principal investigator the lead trial methodologist; she conceived the study and led the proposal and protocol development, as well as the study implementation and data analyses. MN contributed to the study design, development of the proposal, and study implementation. RC contributed to the study design, development of the proposal, and study implementation. CR contributed to the study design, development of the proposal, and study implementation. TK contributed to the study design, development of the proposal, and study implementation. EI contributed to the protocol refinement and study implementation. GF contributed to the protocol refinement and study implementation. LN contributed to the study conceptualization, development of the proposal, and the protocol. MP contributed to the study design, development of the proposal, and study implementation. XMT contributed to the data analyses and the protocol development and implementation. All authors read and approved the final manuscript. National Institute of Health National Institute of Nursing Research (R01 NR016990, PI: Song). NOA letter is attached. Our plans of the study design, data collection and analysis, and dissemination plan have been approved by the funding agency as indicated by the award notice. The members of our research team will have access to the trial dataset that is deidentified once the trial is completed. The final dataset will be available for researchers who are interested in the related topics after the research team has disseminated the main findings of the research aims. Permission from the PI is required for any publications and dissemination effort. The University of North Carolina-Lineberger Comprehensive Cancer Center Cancer (UNC LCCC) Prevention and Control Intervention Research Pilot Grant Award (PI: Song) and UNC LCCC Population Sciences Developmental Research Award (PI: Song) have provided funding for the pilot testing of PERC. We would like to thank the prostate cancer patients, their families, healthcare professionals, and our research staff for their contributions in the pilot studies and our ongoing trial to make the study possible.
Keywords
- Caregiver
- Coping
- Health behavior
- Prostate cancer
- Quality of life
- Randomized clinical trial
- Social support
- Stress
- Symptom management
- eHealth
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)
