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

Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02412124
• Other study ID #: 14359
• Secondary ID: NCI-2015-0046714
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma
• Ovarian Carcinoma
• Ovarian Neoplasms
• Uterine Corpus Cancer
• Vaginal Carcinoma
• Vaginal Neoplasms
• Vulvar Carcinoma
• Vulvar Neoplasms

Intervention

Procedure:
• Supportive Care
Complete W2W mentoring program

Other:
• Quality-of-Life Assessment
Complete the FACT-G
• Questionnaire Administration
Complete the W2W Patient Survey

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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