Culturally Aware AET Non-Initiation Intervention

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465408
• Other study ID #: 22-091
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Jamie M Jacobs, PhD
• Phone: 617-643-1777
• Email: jjacobs[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: February 24, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Survivorship
• Treatment Adherence
• Treatment Compliance
• Treatment Refusal

Intervention

Behavioral:
• Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
One-to-One virtual (videoconference) behavioral intervention.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute at St Elizabeth's Medical Center	Brighton	Massachusetts
United States	Emerson Hospital/MGH Cancer Center	Concord	Massachusetts
United States	Mass General at North Shore Cancer Center	Danvers	Massachusetts
United States	Dana-Farber Brigham Cancer Center - Foxborough	Foxboro	Massachusetts
United States	Dana-Farber/New Hampshire Onoclogy-Hematology	Londonderry	New Hampshire
United States	Dana-Farber Cancer Institute - Merrimack Valley	Methuen	Massachusetts
United States	Dana-Farber Brigham Cancer Center at Milford Regional Medical Center	Milford	Massachusetts
United States	Mass General at Newton Wellesley Hospital	Newton	Massachusetts
United States	Dana-Farber Brigham Cancer Center with South Shore Hospital	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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/12 weeks
Primary	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/12 weeks
Secondary	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.	Baseline (within 1-week of consent), 1-month, and 3-months post-baseline