Breast CancerNCT05465408

Culturally Aware AET Non-Initiation Intervention

A study testing Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention in people with Breast Cancer and Survivorship, run by Massachusetts General Hospital at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Survivorship, Treatment Compliance
What is being tested?: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 11 sitesUnited States
Study dates: 21 Jul 2022to 20 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute at St Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Emerson Hospital/MGH Cancer Center
Concord, Massachusetts, 01742
Mass General at North Shore Cancer Center
Danvers, Massachusetts, 01923
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, 02035
Dana-Farber/New Hampshire Onoclogy-Hematology
Londonderry, New Hampshire, 03053
Dana-Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
Mass General at Newton Wellesley Hospital
Newton, Massachusetts, 02462
Dana-Farber Brigham Cancer Center with South Shore Hospital
Weymouth, Massachusetts, 02190

Other trials in United States

About this study

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

Read the 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
Being tested: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Keywords: Breast Cancer, Survivors, Hormone Therapy, Treatment Refusal, Treatment Compliance, Treatment Adherence
Medical subject headings: Breast Neoplasms, Patient Compliance, Treatment Adherence and Compliance, Treatment Refusal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation InterventionBehavioural
One-to-One virtual (videoconference) behavioral intervention.

Study groups in NCT05465408
Study group	Role	What they receive
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	Experimental	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. Receives: Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Up to 3 months

Secondary outcomes (1)

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.
Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202220 Nov 2024

First posted19 Jul 2022
Study start21 Jul 2022
Primary completion20 Nov 2024
Study completion20 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05465408
Sponsor's protocol ID: 22-091
Status last verified: Feb 2026
First submitted: 15 Jul 2022
Last updated: 24 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Post KE, Dunderdale L, Datta S, Gutierrez N, Varella L, Horick N, Traeger L, Greer JA, Moy B, Temel JS, Jacobs JM. Development and refinement of a nurse-led, culturally sensitive intervention for adjuvant endocrine therapy initiation among patients with breast cancer. Eur J Oncol Nurs. 2025 Dec;79:103010. doi: 10.1016/j.ejon.2025.103010. Epub 2025 Oct 15.
PubMed 41172636

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention
ClinicalTrials.gov ID: NCT05465408
Acronym / sponsor ID: 22-091
Conditions: Breast Cancer, Survivorship, Treatment Compliance, Treatment Adherence, Treatment Refusal
Keywords: Breast Cancer, Survivors, Hormone Therapy, Treatment Refusal, Treatment Compliance, Treatment Adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 21 Jul 2022 (actual)
Primary completion: 20 Nov 2024 (actual)
Study completion: 20 Nov 2024 (actual)
First posted: 19 Jul 2022 (actual)
Results: Posted 24 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The research study procedures include:

screening for eligibility
two individual study intervention sessions
study assessment follow-up questionnaires

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	Experimental	Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation InterventionParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation InterventionOne-to-One virtual (videoconference) behavioral intervention.	Behavioural	Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Primary outcome

Program Feasibility
Time frame: 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).
Program Acceptability
Time frame: 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.

1 secondary outcome

Adjuvant Endocrine Therapy (AET) Initiation
Time frame: Up to 3 months

Results and safety

Results posted to the registry on 24 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	35	27

Primary outcome: Program Feasibility

Time frame: Up to 3 months. Count of participants. Unit: Participants

Measure	Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention n = 77
Enrollment Feasibility: Feasibility	35
Retention Feasibility: Feasibility	28
Attendance Feasibility: Feasibility	29

Population analysed: Seventy-seven patients were eligible and approached for this study. Fourty-three of the 77 remaining patients (55.8%) consented to the study and completed the baseline measures. Six patients were lost to follow-up, and two patients withdrew their consent after completing the baseline questionnaire but before enrollment. Study staff ultimately enrolled 35 of 77 patients (45.5%) in the study. Thirty-five participants were offered the intervention.

Primary outcome: Program Acceptability

Time frame: Up to 3 months. Number. Unit: Participants

Measure	Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention n = 27
Value	25

Population analysed: Three patients withdrew before completing all study procedures. Patient-reported reasons for study withdrawal included that they were no longer interested, felt overwhelmed by residual treatment-related side effects, and/or were busy with clinical visits. Five participants were lost to follow-up. Twenty-seven of the 35 enrolled participants completed the CSQ.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from enrollment until end of follow-up, up to 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Limitations and caveats (from the sponsor): As a single-arm pilot study, we lacked a comparator group to assess INITIATE in comparison to the standard of care or an attention-matched control. The sample size was modest, which limited our ability to evaluate clinically meaningful differences in psychosocial outcomes over the study period. Further, participants mostly had Stage 1 breast cancer, and the study was conducted at an academic medical center; thus, the findings may not be generalizable to all patients with breast cancer.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41172636Post KE, Dunderdale L, Datta S, Gutierrez N, Varella L, Horick N, Traeger L, Greer JA, Moy B, Temel JS, Jacobs JM. Development and refinement of a nurse-led, culturally sensitive intervention for adjuvant endocrine therapy initiation among patients with breast cancer. Eur J Oncol Nurs. 2025 Dec;79:103010. doi: 10.1016/j.ejon.2025.103010. Epub 2025 Oct 15.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jamie M Jacobs, PhD principal investigator

Massachusetts General Hospital

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program Feasibility (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05465408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.