Culturally Aware AET Non-Initiation Intervention

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Treatment Adherence; Survivorship; Treatment Refusal; Treatment Compliance
• Intervention / Treatment: Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie M Jacobs, PhD; Phone Number: 617-643-1777; Email: jjacobs@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Jamie M Jacobs, Phd
      • Principal Investigator: Jamie M Jacobs, PhD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Dana-Farber Cancer Institute at St Elizabeth's Medical Center
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD
    • Concord, Massachusetts, United States, 01742
      • Recruiting
      • Emerson Hospital/MGH Cancer Center
      • Contact: Jamie M Jacobs, Phd
      • Principal Investigator: Jamie M Jacobs, PhD
    • Danvers, Massachusetts, United States, 01923
      • Recruiting
      • Mass General at North Shore Cancer Center
      • Contact: Jamie M Jacobs, Phd
      • Principal Investigator: Jamie M Jacobs, PhD
    • Foxboro, Massachusetts, United States, 02035
      • Recruiting
      • Dana-Farber Brigham Cancer Center - Foxborough
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD
    • Methuen, Massachusetts, United States, 01844
      • Recruiting
      • Dana-Farber Cancer Institute - Merrimack Valley
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD
    • Milford, Massachusetts, United States, 01757
      • Recruiting
      • Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD
    • Newton, Massachusetts, United States, 02462
      • Recruiting
      • Mass General at Newton Wellesley Hospital
      • Contact: Jamie M Jacobs, Phd
      • Principal Investigator: Jamie M Jacobs, PhD
    • Weymouth, Massachusetts, United States, 02190
      • Recruiting
      • Dana-Farber Brigham Cancer Center with South Shore Hospital
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD
  • New Hampshire
    • Londonderry, New Hampshire, United States, 03053
      • Recruiting
      • Dana-Farber/New Hampshire Onoclogy-Hematology
      • Contact: Leticia Varella, MD
      • Sub-Investigator: Leticia Varella, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jamie M Jacobs, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Treatment Adherence; Treatment Compliance; Survivors; Hormone Therapy; Treatment Refusal
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 22-091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No