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Song L, Nielsen ME, Chen RC, et al. 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. Trials. 2022;23(1):12doi: 10.1186/s13063-021-05948-5.
Song, L., Nielsen, M. E., Chen, R. C., Rini, C., Keyserling, T. C., Idiagbonya, E., Fuller, G. P., Northouse, L., Palmer, M. H., & Tan, X. (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. Trials, 23(1), 12. https://doi.org/10.1186/s13063-021-05948-5
Song, Lixin, et al. "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." Trials vol. 23,1 (2022): 12. doi: https://doi.org/10.1186/s13063-021-05948-5
Song L, Nielsen ME, Chen RC, Rini C, Keyserling TC, Idiagbonya E, Fuller GP, Northouse L, Palmer MH, Tan X. 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. Trials. 2022 Jan 04;23(1):12. doi: 10.1186/s13063-021-05948-5. PMID: 34983621.
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Trials. 2022 Jan 04;23(1):12. doi: 10.1186/s13063-021-05948-5.

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.

Trials

Lixin Song, Matthew E Nielsen, Ronald C Chen, Christine Rini, Thomas C Keyserling, Eno Idiagbonya, Gail P Fuller, Laurel Northouse, Mary H Palmer, Xianming Tan

Affiliations

  1. School of Nursing, University of North Carolina (UNC), Chapel Hill, NC, USA. [email protected].
  2. Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, NC, USA. [email protected].
  3. Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, NC, USA.
  4. School of Medicine, UNC, Chapel Hill, NC, USA.
  5. University of Kansas Medical Center, Kansas, USA.
  6. Northwestern University, Cancer Survivorship Institute and Department of Medical Social Sciences, Chicago, USA.
  7. School of Nursing, University of North Carolina (UNC), Chapel Hill, NC, USA.
  8. School of Nursing, University of Michigan, Ann Arbor, MI, USA.
  9. Gillings School of Global Public Health, UNC, Chapel Hill, NC, USA.

PMID: 34983621 DOI: 10.1186/s13063-021-05948-5

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.

© 2022. The Author(s).

Keywords: Caregiver; Coping; Health behavior; Prostate cancer; Quality of life; Randomized clinical trial; Social support; Stress; Symptom management; eHealth

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