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| ID | Type | Description | Link |
|---|---|---|---|
| 854317 | Other Identifier | University of Pennsylvania IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Ambassador | Other | There is one arm of the trial which includes the Patient Ambassador intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Mentee Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
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.
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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 |