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Culturally Aware Support for Hormone Therapy in Breast Cancer Survivors
N/A
Waitlist Available
Led By Jamie M Jacobs, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Must not have
Cognitive impairment that prohibits participation in the study
Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months/12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a nurse-led intervention to support breast cancer survivors who have delayed starting hormone therapy or who have concerns about it.
Who is the study for?
This trial is for female breast cancer survivors, aged 21 or older, with early-stage hormone receptor-positive breast cancer. They must be recommended to start AET but have either delayed it or are hesitant to begin treatment. Participants should be able to communicate in English or Spanish and have a stable physical condition (ECOG ≤ 2). Women from minority communities are especially encouraged to join.
What is being tested?
The study is testing a nurse-led intervention designed to help women who are reluctant or have postponed starting their prescribed hormonal therapy after surviving breast cancer. The focus is on the cultural awareness aspect of the intervention's effectiveness and its overall acceptability among patients.
What are the potential side effects?
Since this trial involves a behavioral intervention rather than medication, traditional side effects associated with drugs aren't expected. However, participants may experience emotional discomfort discussing sensitive topics related to their health decisions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer is in an early stage and hormone receptor-positive.
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I am 21 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cognitive issues that prevent me from joining the study.
Select...
I have not had uncontrolled mental health issues or been hospitalized for them in the past year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months/12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months/12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Program Acceptability
Program Feasibility
Secondary study objectives
Adjuvant endocrine therapy (AET) Initiation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation InterventionExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,754 Total Patients Enrolled
Jamie M Jacobs, PhDPrincipal InvestigatorMassachusetts General Hospital