Patient Ambassador

Not Applicable

• Conditions: Gynecologic Cancer

• Registration Number: NCT06711380
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The overall objective of this study is to design and evaluate a peer ambassador intervention to improve gynecologic cancer trial enrollment. The primary Aim is to determine the possibility of using peer ambassadors to increase discussion, awareness, and enrollment of patients with advanced or recurrent gynecologic cancer onto clinical trials.

Detailed Description

Participants will participate in a peer ambassador program where a patient ambassador (mentor) will be paired with a mentee. The patient ambassador will be a patient with history of gynecologic cancer who has experience with clinical trials and can serve as an ambassador to facilitate discussions regarding education and awareness of clinical trials. This discussion will potentially assist mentees to make informed decisions about their engagement in discussing clinical trials, looking for clinical trials, and desire and acceptance of clinical trials. This will also allow ambassadors to gain information about perceived barriers regarding clinical trials.

The investigators seek to identify patient ambassadors, who will be trained to lead 1:1 discussion with patient mentees. Each ambassador will be paired with up to 5 mentees. Each ambassador-mentee pairing will have 1-2 encounters (meetings) over the course of 12 months. The total number of encounters and the total number of ambassador-mentee dyads created, will be logged.

Enrollment and study visits will occur over a 12 month period. Each mentor will be in the study approximately one year, and each mentee will be in the study approximately 2 months.

Study Timeline

• Study Start: 2024-02-09
• Study First Submitted: 2024-10-18
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Eligible subjects will include those with advanced gynecologic cancer (metastatic or persistent/progressive disease despite primary treatment) or high-risk gynecologic cancer undergoing active systemic therapy not currently enrolled on clinical trials. These patients include those starting a new line of chemotherapy, or who have a diagnosis needing chemotherapy.
• Patients will be identified from the UPHS gynecologic oncology and medical oncology clinics serving gynecologic cancer patients (Penn Medicine Washington Square, PCAM/HUP, Radnor, Chester County, Penn Medicine Cherry Hill). Clinic rosters over 6 months intervals will be screened for eligibility.
• Patients who have been discussed at tumor board conferences and recommended to consider clinical trials will screened for recruitment.

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the ambassador program	12 months	Feasibility of the ambassador program will be assessed using the Feasibility of Intervention Measure (FIM). The FIM is a 4-item questionnaire measuring the feasibility of an intervention.
Acceptability of the ambassador program	12 months	Acceptability of this program will be assessed using AIM (Acceptability of Intervention Measure). The AIM is a 4-item questionnaire measuring the acceptability of an intervention.
Intention	12 months	Intention to recommend the ambassador program will be assessed using the Net Promoter Score (NPS) measure. NPS instrument is attached in the appendix and does not require any licensing agreement for use in this research study. Participants will be asked to rate the likelihood of their referral of the program on a scale of zero to ten (zero to six is a "Detractor", while scores of seven to eight are "Passives" and scores of nine and ten are "Promoters").

Secondary Outcome Measures

Name	Time	Method
Mentee knowledge	2 months	Mentee knowledge regarding clinical trials before and after their discussion session(s) with ambassador. This will be assessed using a knowledge of clinical trials questionnaire.
Sociodemographic	2 months	Sociodemographic and clinical factors associated with feasibility, acceptability, and likelihood to recommend this program.
Clinical trial enrollment	12 months	Proportion of mentees in this program who enrolled onto a clinical trial

Trial Locations

Locations (1)

Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States