Clinical trial NCT02412124: Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers
Official title: Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Carcinoma
Ovarian Carcinoma
Uterine Corpus Cancer
Vaginal Carcinoma
Vulvar Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-04-08
Enrollment: 3
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life benefits for patients, as assessed by the FACT-G
timeFrame: Baseline to up to 12 months
measure: Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
timeFrame: Up to 12 months
measure: Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
timeFrame: Up to 12 months
measure: Satisfaction of patients' family caregivers with the timing, content, and format of the program
timeFrame: Up to 12 months
measure: Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Thanh Dellinger, MD
role: PRINCIPAL_INVESTIGATOR
References: