NCT05465408

Culturally Aware AET Non-Initiation Intervention

Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Breast Cancer
• Survivorship
• Treatment Compliance
• Treatment Adherence
• Treatment Refusal

Interventions

Type	Name	Description
BEHAVIORAL	Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	One-to-One virtual (videoconference) behavioral intervention.

Timeline

• Start date: 2022-07-21
• Primary completion: 2024-11-20
• Completion: 2024-11-20
• First posted: 2022-07-19
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

11 sites across 1 country: United States