Culturally Aware AET Non-Initiation Intervention

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05465408

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

7.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Survivorship Treatment Compliance Treatment Adherence Treatment Refusal	Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention	N/A

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 about 30 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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Program Feasibility [Up to 3 months/12 weeks]
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 [Up to 3 months/12 weeks]
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.

Secondary Outcome Measures

Adjuvant endocrine therapy (AET) Initiation [Baseline (within 1-week of consent), 1-month, and 3-months post-baseline]
Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
2	Emerson Hospital/MGH Cancer Center	Concord	Massachusetts	United States	01742
3	Mass General at North Shore Cancer Center	Danvers	Massachusetts	United States	01923
4	Mass General at Newton Wellesley Hospital	Newton	Massachusetts	United States	02462