Culturally Aware AET Non-Initiation Intervention
- Conditions
- Breast CancerSurvivorshipTreatment AdherenceTreatment RefusalTreatment Compliance
- Registration Number
- NCT05465408
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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 begun taking 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 sessions either in-person or via telephone. Participants will also complete three brief questionnaire packets over the 12-week course of the study.
It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample for patients of a racial and/or ethnic minority in order to ensure the generalizability of the study findings.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
- Female
- Age 21 or older
- Diagnosis of early-stage (Stage 0-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
- Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year
- Cognitive impairment that prohibits participation in the study
- Undergoing primary treatment for other cancer (i.e., advanced stage cancer)
- Participating in a clinical trial involving AET
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Program Feasibility Up to 3 months/12 weeks 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 Up to 3 months/12 weeks 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.
- Secondary Outcome Measures
Name Time Method Adjuvant endocrine therapy (AET) Initiation Baseline (within 1-week of consent), 1-month, and 3-months post-baseline Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.
Trial Locations
- Locations (11)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute at St Elizabeth's Medical Center
🇺🇸Brighton, Massachusetts, United States
Emerson Hospital/MGH Cancer Center
🇺🇸Concord, Massachusetts, United States
Mass General at North Shore Cancer Center
🇺🇸Danvers, Massachusetts, United States
Dana-Farber Brigham Cancer Center - Foxborough
🇺🇸Foxboro, Massachusetts, United States
Dana-Farber Cancer Institute - Merrimack Valley
🇺🇸Methuen, Massachusetts, United States
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
🇺🇸Milford, Massachusetts, United States
Mass General at Newton Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Dana-Farber Brigham Cancer Center with South Shore Hospital
🇺🇸Weymouth, Massachusetts, United States
Scroll for more (1 remaining)Massachusetts General Hospital Cancer Center🇺🇸Boston, Massachusetts, United States