An interventional study of Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention in Breast Cancer, Survivorship and Treatment Compliance, sponsored by Massachusetts General Hospital. Completed at 11 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
One-to-One virtual (videoconference) behavioral intervention.
Program Feasibility
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).
Time frame: Up to 3 months
Program Acceptability
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.
Time frame: Up to 3 months
Adjuvant Endocrine Therapy (AET) Initiation
Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.
Time frame: Up to 3 months
From July 2022 to August 2024, study staff invited patients with early-stage, HR+ breast cancer to participate in the INITATE intervention. This study was conducted at the Massachusetts General Hospital (MGH) Cancer Center, three MGH community affiliates, and the Dana-Farber Cancer Institute. Study staff identified potentially eligible patients through EHR review from the participating site's breast oncology clinics. Study staff then approached potentially eligible patients via telephone.
| Milestone | Experimental: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Started | 35 |
| Completed | 27 |
| Not completed | 8 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 3 |
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).
| Participants | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Enrollment Feasibility — Feasibility | 35 |
| Retention Feasibility — Feasibility | 28 |
| Attendance Feasibility — Feasibility | 29 |
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.
| Participants | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Program Acceptability | 25 |
Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.
| Participants | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| 1-Month Post-Baseline — Initiated AET | 23 |
| 1-Month Post-Baseline — Did not initiate AET | 4 |
| 3-Months Post-Baseline — Initiated AET | 24 |
| 3-Months Post-Baseline — Did not initiate AET | 3 |
Collected over Adverse event data was collected from enrollment until end of follow-up, up to 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
No participants were excluded from analyses at baseline.
| Age, Continuous(Years) | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Mean | 55.8 ± 12.0 |
| Sex/Gender, Customized(Participants) | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Gender — Woman | 35 |
| Gender — Man | 0 |
| Race/Ethnicity, Customized(Participants) | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Race — White or of European background | 24 |
| Race — Asian, Asian American or of Asian background | 5 |
| Race — Black, African American or of African background | 4 |
| Race — Option not listed | 2 |
| Race/Ethnicity, Customized(Participants) | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Ethnicity — Hispanic or Latino/a/x | 5 |
| Ethnicity — Not Hispanic or Latino/a/x | 29 |
| Ethnicity — Not reported | 1 |
| Number of Participants who Initiated their Hormonal Therapy(Participants) | Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention |
|---|---|
| Count of participants | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf
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Massachusetts General Hospital