Key result
An enhanced survivorship care plan with a couple-focused mHealth program is being evaluated for feasibility in a randomized pilot trial of 50 prostate cancer patients and their partners.
Why the study?
Does an enhanced survivorship care plan (ESCP) improve feasibility and quality of life in patients completing initial treatment for localized prostate cancer and their partners?
RCT (n=100)
Single-blind
Stratified permuted block randomization
Yes
Does an enhanced survivorship care plan (ESCP) improve feasibility and quality of life in patients completing initial treatment for localized prostate cancer and their partners?
This protocol outlines a feasibility study for an enhanced survivorship care plan using an mHealth program for prostate cancer patients and their partners.
Leaves open whether enhanced survivorship care improves prostate cancer couple outcomes; pilot feasibility data will guide larger trials.
BACKGROUND: This project explores a new model of care that enhances survivorship care planning and promotes health for men with localized prostate cancer transitioning to posttreatment self-management. Survivorship care planning is important for patients with prostate cancer because of its high incidence rate in the United States, the frequent occurrence of treatment-related side effects, and reduced quality of life (QOL) for both men and their partners. A key component of comprehensive survivorship care planning is survivorship care plans (SCPs), documents that summarize cancer diagnosis, treatment, and plans for follow-up care. However, research concerning the effectiveness of SCPs on patient outcomes or health service use has thus far been inconclusive. SCPs that are tailored to individual patients' needs for information and care may improve effectiveness. OBJECTIVE: This study aims to examine the feasibility of an enhanced survivorship care plan (ESCP) that integrates a symptom self-management mHealth program called Prostate Cancer Education and Resources for Couples (PERC) into the existing standardized SCP. The specific aims are to (1) examine the feasibility of delivering ESCPs and (2) to estimate the magnitude of benefit of ESCPs. METHODS: We will use a two-group randomized controlled pretest-posttest design and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, we will assess the feasibility of ESCP by recruitment, enrollment, and retention rates; program satisfaction with the ESCP; and perceived ease of use of the ESCP. To achieve the secondary aim, we will compare the ESCP users with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL); secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms); and number of visits to posttreatment care services between T1 and T2. We will assess the primary and secondary outcomes using measurements with sound psychometrical properties. We will use a qualitative and quantitative mixed methods approach to achieve the research aims. RESULTS: This project is ongoing and will be completed by the end of 2018. CONCLUSIONS: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.
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Song et al. (2018) conducted an RCT in Localized prostate cancer (n=100). Enhanced survivorship care plan (ESCP) with PERC mHealth program vs. Standardized survivorship care plan (SCP) with NCI website was evaluated on Feasibility (recruitment, enrollment, and retention rates; program satisfaction; perceived ease of use). An enhanced survivorship care plan with a couple-focused mHealth program is being evaluated for feasibility in a randomized pilot trial of 50 prostate cancer patients and their partners.
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