Culturally Aware AET Non-Initiation Intervention

Mass General Brigham

Status: Enrolling

Conditions: Breast Cancer; Survivorship; Treatment Adherence; Treatment Compliance; Treatment Refusal

Treatments: Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05465408

22-091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention