Culturally Aware AET Non-Initiation Intervention

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Survivorship; Treatment Adherence; Treatment Refusal; Treatment Compliance
• Interventions: Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

• 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.

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Study Start: 2022-07-21
• Status Verified: 2024-11
• Primary Completion: 2024-11-20
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	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.

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

Dana-Farber/New Hampshire Onoclogy-Hematology; 🇺🇸 Londonderry, New Hampshire, United States