N/A
N=35
Culturally Aware AET Non-Initiation Intervention
Breast Cancer · Survivorship · Treatment Compliance · Treatment Adherence · Treatment Refusal
Bottom Line
View on ClinicalTrials.gov: NCT05465408 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Program Feasibility — 35; 28; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Program Feasibility |
35; 28; 29 | — |
| PRIMARY Program Acceptability |
25 | — |
| SECONDARY Adjuvant Endocrine Therapy (AET) Initiation |
23; 4; 24; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female
- 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
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 another cancer (i.e., advanced-stage cancer)
- Participating in a clinical trial involving AET
Data sourced from ClinicalTrials.gov (NCT05465408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.