Breast Cancer Clinical Trial
Culturally Aware AET Non-Initiation Intervention
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.
Full 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.
Eligibility Criteria
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
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There are 4 Locations for this study
Boston Massachusetts, 02114, United States More Info
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Principal Investigator
Concord Massachusetts, 01742, United States More Info
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Principal Investigator
Danvers Massachusetts, 01923, United States More Info
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Principal Investigator
Newton Massachusetts, 02462, United States More Info
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Principal Investigator
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