Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- Program Feasibility
研究概览
简要总结
The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.
详细描述
This is a single-arm pilot trial to examine the feasibility and acceptability of a patient-centered, evidence-based, culturally competent, nurse-led intervention to encourage breast cancer survivors who have not started their adjuvant endocrine therapy (AET) to initiate the medication.
The research study procedures include:
- screening for eligibility
- two individual study intervention sessions
- study assessment follow-up questionnaires
This research study involves two individual sessions with a nurse practitioner, which will take place via videoconferencing, in person, or by telephone. Participants will also complete three brief questionnaire packets over the 12-week study period.
It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample with patients from racial and/or ethnic minority groups to ensure the generalizability of the study findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age 21 or older
- •Diagnosis of early-stage (Stage I-IIIB), hormone receptor-positive breast cancer
- •Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start AET in the future, and reports hesitations to start AET as determined by a score of >/= 4 (range =0-10) when asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)"
- •Ability to read and respond in English or Spanish
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •For at least 10 participants, identify as a member of a racial or ethnic minority community per self-report
排除标准
- •Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year
- •Cognitive impairment that prohibits participation in the study
- •Undergoing primary treatment for another cancer (i.e., advanced-stage cancer)
- •Participating in a clinical trial involving AET
研究组 & 干预措施
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
干预措施: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention (Behavioral)
结局指标
主要结局
Program Feasibility
时间窗: Up to 3 months
Feasibility will be demonstrated by enrollment (\>50% of eligible and approached patients will enroll), retention (\>70% of enrolled participants will complete the two intervention sessions) and attendance (≥70% of participants completing at least one session).
Program Acceptability
时间窗: Up to 3 months
Acceptability will be demonstrated by \>75% of participants reporting average satisfaction scores greater than the mid-point of the Client Satisfaction Questionnaire. The total score range is 3-12, with higher scores indicating a better outcome.
次要结局
- Adjuvant Endocrine Therapy (AET) Initiation(Up to 3 months)
研究者
Jamie Jacobs
Principal Investigator
Massachusetts General Hospital