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

NCT02412124 — Not applicable, Terminated, 3 participants, City of Hope Medical Center

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

RegistryNCT02412124
StatusTerminated - Feasibility issues
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, supportive care
Enrollment3 (Actual)
SponsorCity of Hope Medical Center (Other); collaborators: National Cancer Institute (NCI)
ConditionsCervical Carcinoma, Ovarian Carcinoma, Uterine Corpus Cancer, Vaginal Carcinoma, Vulvar Carcinoma
InterventionsSupportive Care, Quality-of-Life Assessment, Questionnaire Administration (Procedure, other)
Datesstart 2015-07-23, primary completion 2018-04-26, completion 2018-04-26, first posted 2015-04-08, last updated 2026-10-20
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Supportive care (W2W program)ExperimentalProcedure: Supportive Care; Other: Quality-of-Life Assessment; Other: Questionnaire AdministrationPatients 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 (Procedure), also known as Supportive Therapy, Symptom Management, Therapy, Supportive: Complete W2W mentoring program
  • Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Complete the FACT-G
  • Questionnaire Administration (Other): Complete the W2W Patient Survey

+Outcome measures

Primary outcomes

  • 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 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.
  • 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.

+Eligibility

Sex: Female, ages: 19 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
City of Hope Medical CenterDuarte, CaliforniaUnited States

+Investigators

My Notes