NCT05465408

Culturally Aware AET Non-Initiation Intervention

Completed NA Results posted Last updated 24 February 2026

What this trial tests

NA trial testing Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention in Breast Cancer in 35 participants. Completed in 20 November 2024.

Timeline

21 July 2022

Primary endpoint
20 November 2024

20 November 2024

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	35
Start date	21 July 2022
Primary completion	20 November 2024
Estimated completion	20 November 2024
Sites	11 locations across United States

Drugs / interventions tested

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

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Survivorship — all drugs for Survivorship →
• Treatment Compliance — all drugs for Treatment Compliance →
• Treatment Adherence — all drugs for Treatment Adherence →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, female only, with Breast Cancer or Survivorship. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Program Feasibility Primary · Up to 3 months

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).

Enrollment Feasibility

Group	Value	95% CI
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	35

Retention Feasibility

Group	Value	95% CI
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	28

Attendance Feasibility

Group	Value	95% CI
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	29

Program Acceptability Primary · Up to 3 months

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.

Group	Value	95% CI
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	25

Adjuvant Endocrine Therapy (AET) Initiation Secondary · Up to 3 months

Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.

1-Month Post-Baseline

Group	Value	95% CI
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	23
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	4

3-Months Post-Baseline

Group	Value	95% CI
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	24
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and refinement of a nurse-led, culturally sensitive intervention for adjuvant endocrine therapy initiation among patients with breast cancer.
   Post KE, Dunderdale L, Datta S, Gutierrez N, et al · · 2025 · PMID 41172636 · DOI 10.1016/j.ejon.2025.103010