NCT06711380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 24, 2026

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

October 18, 2024

Last Update Submit

February 20, 2026

Conditions

Keywords

mentorambassadorgynecologic cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Mentee knowledge

    2 months

  • Sociodemographic

    2 months

  • Clinical trial enrollment

    12 months

Study Arms (1)

Peer Ambassador

OTHER

There is one arm of the trial which includes the Patient Ambassador intervention.

Other: Peer Ambassador

Interventions

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).

Peer Ambassador

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Pennsylvania Hospital Abramson Cancer Center, Director, Gynecologic Oncology Populations Sciences Research Program, Director, REACH - Research Equity Center for Gynecologic Cancers and Health

Study Record Dates

First Submitted

October 18, 2024

First Posted

December 2, 2024

Study Start

February 9, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 24, 2026

Record last verified: 2024-11

Locations