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

NCT ID: NCT02412124

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-04-30

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.

Conditions

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Cervical Carcinoma Ovarian Carcinoma Uterine Corpus Cancer Vaginal Carcinoma Vulvar Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supportive Care

Intervention Type PROCEDURE

Complete W2W mentoring program

Quality-of-Life Assessment

Intervention Type OTHER

Complete the FACT-G

Questionnaire Administration

Intervention Type OTHER

Complete the W2W Patient Survey

Interventions

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Supportive Care

Complete W2W mentoring program

Intervention Type PROCEDURE

Quality-of-Life Assessment

Complete the FACT-G

Intervention Type OTHER

Questionnaire Administration

Complete the W2W Patient Survey

Intervention Type OTHER

Other Intervention Names

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Supportive Therapy Symptom Management Therapy, Supportive Quality of Life Assessment

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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thanh Dellinger, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-00467

Identifier Type: REGISTRY

Identifier Source: secondary_id

14359

Identifier Type: OTHER

Identifier Source: secondary_id

14359

Identifier Type: -

Identifier Source: org_study_id

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