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

Prostate Cancer Clinical Trial

— SCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350788
• Other study ID #: LCCC 1619
• Secondary ID: 1R21CA212516
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: September 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 15, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Survivorship Care Plan
Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care
• Enhanced Survivorship Care Plan
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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in FACT-G Scores	Change in QOL determined using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change from baseline is the post-Baseline values minus the Baseline value.	Baseline upon enrollment, Month 4
Secondary	Change in Appraisal of Prostate Cancer-Specific Symptoms	The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in appraisal of symptoms scores among patients from Baseline (T1) to T2 (4 months post T1). EPIC contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing opposite results by role: patient with better appraisal of symptoms and partner with worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.	Baseline upon enrollment, Month 4
Secondary	Change in Appraisal of General Symptoms	The 19-item Risk for Distress-general symptoms is a subscale of the Risk for Distress Scale. It measures how much trouble the participant has with the general symptoms such as pain, fatigue, and etc. The total score ranges between 0 and 38, with higher scores indicating worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.	Baseline upon enrollment, Month 4
Secondary	Healthcare Utilization Extracted From Electronic Medical Record	The total number of prostate cancer-related followup visits, emergency room use and readmissions.	during the first 10 months after participants completed baseline survey
Secondary	Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline	The Lewis Cancer Self-Efficacy used to measure change in participants' feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1). Participants rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.	Baseline upon enrollment, Month 4
Secondary	Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline	The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more informational support. Change from baseline is the post-Baseline values minus the Baseline value.	Baseline upon enrollment, Month 4
Secondary	Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline	The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more emotional social support. Change from baseline is the post-Baseline values minus the Baseline value.	Baseline upon enrollment, Month 4
Secondary	Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline	The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more instrumental support. Change from baseline is the post-Baseline values minus the Baseline value.	Baseline upon enrollment, Month 4
Secondary	Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II	Change in Dietary Risk Assessment scores used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they consume different foods over the past month or week and respond using a Likert Scale ranging from 1=never to 4=routinely. The total score range: 8-32. Higher scores indicate better health behaviors in nutrition.	Baseline upon enrollment, Month 4
Secondary	Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II	Change in Physical Activity Assessment scores used to measure changes in physical activity from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they engage in exercises and physical activity over the past month or week and respond using a Likert Scale, ranging from 1=never to 4=routinely. The total score range: 9-36. Higher scores indicate better health behaviors in physical activity.	Baseline upon enrollment, Month 4