Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
SCP
2 other identifiers
interventional
124
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Aug 2017
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedResults Posted
Study results publicly available
September 23, 2020
CompletedSeptember 23, 2020
September 1, 2020
1.3 years
March 28, 2020
June 11, 2020
September 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
after participants completed baseline survey
Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).
during 4-month study period
Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group. Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms. 1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed
during 4-month study period
Participant Satisfaction Scores
Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction. The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied. The eleventh item ranged from 1=extremely not to 4=definitely yes. Higher total score indicates greater program satisfaction
at the 4 month followup
Perceived Ease of Use Score
The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation. The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively. The score of individual item ranges from1=strongly disagree to 5=strongly agree. Higher score indicates greater perceived ease of use.
at the 4 month followup
Secondary Outcomes (10)
Change in FACT-G Scores
Baseline upon enrollment, Month 4
Change in Appraisal of Prostate Cancer-Specific Symptoms
Baseline upon enrollment, Month 4
Change in Appraisal of General Symptoms
Baseline upon enrollment, Month 4
Healthcare Utilization Extracted From Electronic Medical Record
during the first 10 months after participants completed baseline survey
Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline
Baseline upon enrollment, Month 4
- +5 more secondary outcomes
Study Arms (2)
Survivorship Care Plan (SCP)
PLACEBO COMPARATORThe SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),
Enhanced SCP (ESCP)
EXPERIMENTALESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.
Interventions
Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care
In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Either member of couple unable to speak English
- Unwilling/unable to provide Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559, United States
Related Publications (1)
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.
PMID: 32681304DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biostatistician
- Organization
- UNC-CH School of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Lixin Song, RN, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2020
First Posted
April 17, 2020
Study Start
August 3, 2017
Primary Completion
November 30, 2018
Study Completion
April 15, 2019
Last Updated
September 23, 2020
Results First Posted
September 23, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 9 to 36 months following publication
- Access Criteria
- Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.