Culturally Aware AET Non-Initiation Intervention
Purpose
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.
Conditions
- Breast Cancer
- Survivorship
- Treatment Compliance
- Treatment Adherence
- Treatment Refusal
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Boston, Massachusetts 02114
Jamie M Jacobs, PhD
Concord, Massachusetts 01742
Jamie M Jacobs, PhD
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.