Prostate Cancer Clinical Trial
Official title:
Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
The purpose of this research study is to examine the feasibility of the enhanced survivorship
care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management
project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an
initial benefit assessment of enhanced survivorship care plans among prostate cancer patients
transitioning from active treatment to post-treatment self-management, and their partners.
Participation of this study lasts for about for 16 weeks. Depending on participants' need for
information, it takes 10-30 minutes of their time each week to review the information about
prostate cancer.
Eligible and consented patients with newly treated localized prostate cancer and your partner
(couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI
website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer
education program, PERC) groups. They complete baseline (T1, prior to randomization) and
4-month post-T1 follow-up measures (T2).
Methods: A two-group randomized controlled pretest-posttest design will be used 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, the investigators 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, the ESCP
users will be compared 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 post-treatment care services at T1 and T2. The primary and
secondary outcomes are assessed using measurements with sound psychometrical properties. The
investigators will use a qualitative and quantitative mixed methods approach to achieve the
research aims.
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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