Clinical trial NCT04350788: Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
Official title: Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: survivorship care plan
quality of life
supportive care
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-17
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Eligibility included men who:

* were diagnosed with localized PC;
* were within 16 weeks of completing their initial curative intent treatment \[26\] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast;
* were not treated for another cancer in last year; and
* had a partner \> 18 years of age not receiving cancer treatment.

Exclusion Criteria:

* Either member of couple unable to speak English
* Unwilling/unable to provide Informed Consent

Primary outcomes:
measure: Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
timeFrame: after participants completed baseline survey
measure: Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
timeFrame: during 4-month study period
measure: Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
timeFrame: during 4-month study period
measure: Participant Satisfaction Scores
timeFrame: at the 4 month followup
measure: Perceived Ease of Use Score
timeFrame: at the 4 month followup
Secondary outcomes:
measure: Change in FACT-G Scores
timeFrame: Baseline upon enrollment, Month 4
measure: Change in Appraisal of Prostate Cancer-Specific Symptoms
timeFrame: Baseline upon enrollment, Month 4
measure: Change in Appraisal of General Symptoms
timeFrame: Baseline upon enrollment, Month 4
measure: Healthcare Utilization Extracted From Electronic Medical Record
timeFrame: during the first 10 months after participants completed baseline survey
measure: Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline
timeFrame: Baseline upon enrollment, Month 4
measure: Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline
timeFrame: Baseline upon enrollment, Month 4
measure: Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline
timeFrame: Baseline upon enrollment, Month 4
measure: Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline
timeFrame: Baseline upon enrollment, Month 4
measure: Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
timeFrame: Baseline upon enrollment, Month 4
measure: Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
timeFrame: Baseline upon enrollment, Month 4
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lixin Song, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song L, Guo P, Tan X, Chen RC, Nielsen ME, Birken SA, Koontz BF, Northouse LL, Mayer DK. Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. J Cancer Surviv. 2021 Feb;15(1):99-108. doi: 10.1007/s11764-020-00914-7. Epub 2020 Jul 17.