Patient Ambassador in Gynecologic Oncology Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Feasibility of the ambassador program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Peer Ambassador
There is one arm of the trial which includes the Patient Ambassador intervention.
干预措施: Peer Ambassador (Other)
结局指标
主要结局
Feasibility of the ambassador program
时间窗: 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
时间窗: 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
时间窗: 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").
次要结局
- Mentee knowledge(2 months)
- Sociodemographic(2 months)
- Clinical trial enrollment(12 months)
研究者
Emily Ko, MD
Medical Director, Pennsylvania Hospital Abramson Cancer Center, Director, Gynecologic Oncology Populations Sciences Research Program, Director, REACH - Research Equity Center for Gynecologic Cancers and Health
Abramson Cancer Center at Penn Medicine