N/A Completed N=124 Randomized Double-blind Supportive Care

Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program

Prostate Cancer

Source: ClinicalTrials.gov NCT04350788 ↗

Enrolled (actual)

124

Serious AEs

1.6%

Results posted

Sep 2020

Primary outcomePrimary: Percentage of Potentially Eligible Participants Actually Enrolled Into the Study — 62 dyad

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Potentially Eligible Participants Actually Enrolled Into the Study	62	—
PRIMARY Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey	25; 28	—
PRIMARY Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms	13	—
PRIMARY Participant Satisfaction Scores	30.48; 36.30; 36.29; 38.59	0.02 sig
PRIMARY Perceived Ease of Use Score	12.44; 12.60; 12.68; 12.53; 17.11; 17.32	0.36
SECONDARY Change in FACT-G Scores	-0.03; 1.91	0.35
SECONDARY Change in Appraisal of Prostate Cancer-Specific Symptoms	11.03; 19.58; -0.48; -0.46; 2.31; 6.93	0.01 sig
SECONDARY Change in Appraisal of General Symptoms	-1.26; -2.97; -0.59; -1.35	0.18
SECONDARY Healthcare Utilization Extracted From Electronic Medical Record	4.84; 4.65	0.05
SECONDARY Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline	-1.40; 0.50	0.10
SECONDARY Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline	-0.09; 0.98	0.29
SECONDARY Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline	0.02; 0.29	0.49
SECONDARY Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline	-0.76; -0.21	0.09
SECONDARY Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II	-0.10; -0.10	0.16
SECONDARY Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II	-0.02; -0.01	0.55

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04350788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.