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OpenTrials
Completed

NCT Number: NCT06711380

Patient Ambassador

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Ambassador

Other

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).

Primary outcomes

  1. Feasibility of the ambassador program

    Time frame: 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.

  2. Acceptability of the ambassador program

    Time frame: 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.

  3. Intention

    Time frame: 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 outcomes

  1. Mentee knowledge

    Time frame: 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.

  2. Sociodemographic

    Time frame: 2 months

    Sociodemographic and clinical factors associated with feasibility, acceptability, and likelihood to recommend this program.

  3. Clinical trial enrollment

    Time frame: 12 months

    Proportion of mentees in this program who enrolled onto a clinical trial

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Patient Ambassador in Gynecologic Oncology Clinical Trials

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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