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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer

Conditions
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Cervical Carcinoma, Ovarian Carcinoma, Uterine Corpus Cancer, Vaginal Carcinoma, Vulvar Carcinoma

Intervention / Treatment
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* Procedure: Supportive Care
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (W2W program)<br>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. | Procedure: Supportive Care<br>* Complete W2W mentoring program<br>* Other names: Therapy, Supportive;Other: Quality-of-Life Assessment<br>* Complete the FACT-G<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete the W2W Patient Survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life benefits for patients, as assessed by the FACT-G | 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. | Baseline to up to 12 months | 
| Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey | 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. | Up to 12 months | 
| Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey | 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. | Up to 12 months | 
| Satisfaction of patients' family caregivers with the timing, content, and format of the program | 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. | Up to 12 months | 
| Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index | 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. | Up to 12 months |