Culturally Aware AET Non-Initiation Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Survivorship, Treatment Compliance, Treatment Adherence, Treatment Refusal

Intervention / Treatment
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* Behavioral: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention<br>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<br>* One-to-One virtual (videoconference) behavioral intervention.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Survivors, Hormone Therapy, Treatment Refusal, Treatment Compliance, Treatment Adherence