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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02412124
Collaborator
National Cancer Institute (NCI) (NIH)
3
Enrollment
1
Location
1
Arm
33
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Supportive Care
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (W2W program)

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
Complete W2W mentoring program
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive

    • Other: Quality-of-Life Assessment
    Complete the FACT-G
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Complete the W2W Patient Survey

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Thanh Dellinger, MD, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT02412124
    Other Study ID Numbers:
    • 14359
    • NCI-2015-00467
    • 14359
    First Posted:
    Apr 8, 2015
    Last Update Posted:
    May 11, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:
    Carcinoma
    Vulvar Neoplasms
    Vaginal Neoplasms

    Study Results

    No Results Posted as of May 11, 2018