Study Stopped
Feasibility issues
Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers
Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
2 other identifiers
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 11, 2018
May 1, 2018
2.8 years
April 3, 2015
May 4, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
Supportive care (W2W program)
EXPERIMENTALPatients 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.
Interventions
Complete W2W mentoring program
Complete the FACT-G
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- PEER MENTORS:
- Major psychiatric disease
- Currently undergoing treatment for active gynecologic cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thanh Dellinger, MD
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2015
First Posted
April 8, 2015
Study Start
July 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
May 11, 2018
Record last verified: 2018-05