Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers

Not Applicable

Terminated

• Conditions: Cervical Carcinoma; Vaginal Carcinoma; Ovarian Carcinoma; Uterine Corpus Cancer; Vulvar Carcinoma
• Interventions: Procedure: Supportive Care; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02412124
• Lead Sponsor: City of Hope Medical Center

Brief Summary

This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.

Detailed Description

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?

OUTLINE:

Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.

After completion of study, patients are followed up at 6 and 12 months.

Study Timeline

• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Study Start: 2015-07
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• PATIENT PARTICIPANTS
• Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
• English-speaking patients
• PEER MENTORS
• Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
• Over age 18
• PEER MENTORS: English-speaking patients
• This study is open to patients of all races and ethnicities

Exclusion Criteria

• PEER MENTORS:
• Major psychiatric disease
• Currently undergoing treatment for active gynecologic cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (W2W program)	Questionnaire Administration	Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
Supportive care (W2W program)	Quality-of-Life Assessment	Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
Supportive care (W2W program)	Supportive Care	Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.

Primary Outcome Measures

Name	Time	Method
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey	Up to 12 months	Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Change in quality of life benefits for patients, as assessed by the FACT-G	Baseline to up to 12 months	Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey	Up to 12 months	Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Satisfaction of patients' family caregivers with the timing, content, and format of the program	Up to 12 months	Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index	Up to 12 months	Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States