Clinical trial NCT05465408: Culturally Aware AET Non-Initiation Intervention
Official title: Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Survivorship
Treatment Compliance
Treatment Adherence
Treatment Refusal
Keywords: Breast Cancer
Survivors
Hormone Therapy
Treatment Refusal
Treatment Compliance
Treatment Adherence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 begun taking 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 sessions either in-person or via telephone. Participants will also complete three brief questionnaire packets over the 12-week course of the study.

It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample for patients of a racial and/or ethnic minority in order to ensure the generalizability of the study findings.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 21 or older
* Diagnosis of early-stage (Stage 0-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 other cancer (i.e., advanced stage cancer)
* Participating in a clinical trial involving AET

Primary outcomes:
measure: Program Feasibility
timeFrame: Up to 3 months/12 weeks
measure: Program Acceptability
timeFrame: Up to 3 months/12 weeks
Secondary outcomes:
measure: Adjuvant endocrine therapy (AET) Initiation
timeFrame: Baseline (within 1-week of consent), 1-month, and 3-months post-baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Brighton
country: United States
facility: Dana-Farber Cancer Institute at St Elizabeth's Medical Center
state: Massachusetts
city: Concord
country: United States
facility: Emerson Hospital/MGH Cancer Center
state: Massachusetts
city: Danvers
country: United States
facility: Mass General at North Shore Cancer Center
state: Massachusetts
city: Foxboro
country: United States
facility: Dana-Farber Brigham Cancer Center - Foxborough
state: Massachusetts
city: Methuen
country: United States
facility: Dana-Farber Cancer Institute - Merrimack Valley
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Mass General at Newton Wellesley Hospital
state: Massachusetts
city: Weymouth
country: United States
facility: Dana-Farber Brigham Cancer Center with South Shore Hospital
state: Massachusetts
city: Londonderry
country: United States
facility: Dana-Farber/New Hampshire Onoclogy-Hematology
state: New Hampshire
Study officials:
affiliation: Massachusetts General Hospital
name: Jamie M Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References: