Patient Ambassador

Patient Ambassador in Gynecologic Oncology Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Peer Ambassador

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Mentee 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Peer Ambassador; There is one arm of the trial which includes the Patient Ambassador intervention.	Other: Peer Ambassador; Patient mentor (patient with history of gynecologic cancer who has experience with clinical trials) one on one discussion with patient mentee (patient receiving standard of care treatment for gynecologic cancers).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the ambassador program	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.	12 months
Acceptability of the ambassador program	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.	12 months
Intention	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").	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mentee knowledge	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.	2 months
Sociodemographic	Sociodemographic and clinical factors associated with feasibility, acceptability, and likelihood to recommend this program.	2 months
Clinical trial enrollment	Proportion of mentees in this program who enrolled onto a clinical trial	12 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ambassador; gynecologic cancer; mentor
• Other Study ID Numbers: UPCC 33823; 854317 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will share data arising from the proposed project to the extent that it is permissible and consistent with the prevailing data use agreements and controlling IRBs. Data sharing will occur in a timely fashion. Following acceptance for publication of the main findings from the final data set, the investigators will provide for the timely release and sharing of the de-identified data from the cohort study and the qualitative interviews. These data sets will be provided upon written request to all interested investigators. Upon acceptance for publication of the main study findings, the investigators will also share upon written request with interested investigators the code used in analyzing data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No