Culturally Aware AET Non-Initiation Intervention
Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention
1 other identifier
interventional
35
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jul 2022
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedStudy Start
First participant enrolled
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2024
CompletedResults Posted
Study results publicly available
February 24, 2026
CompletedFebruary 24, 2026
February 1, 2026
2.3 years
July 15, 2022
January 16, 2026
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
Up to 3 months
Secondary Outcomes (1)
Adjuvant Endocrine Therapy (AET) Initiation
Up to 3 months
Study Arms (1)
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
EXPERIMENTALParticipants 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.
Interventions
One-to-One virtual (videoconference) behavioral intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute at St Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Emerson Hospital/MGH Cancer Center
Concord, Massachusetts, 01742, United States
Mass General at North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, 02035, United States
Dana-Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844, United States
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
Mass General at Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
Dana-Farber Brigham Cancer Center with South Shore Hospital
Weymouth, Massachusetts, 02190, United States
Dana-Farber/New Hampshire Onoclogy-Hematology
Londonderry, New Hampshire, 03053, United States
Related Publications (1)
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.
PMID: 41172636DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Jamie Jacobs
- Organization
- The Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie M Jacobs, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 15, 2022
First Posted
July 19, 2022
Study Start
July 21, 2022
Primary Completion
November 20, 2024
Study Completion
November 20, 2024
Last Updated
February 24, 2026
Results First Posted
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.