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Culturally Aware Support for Hormone Therapy in Breast Cancer Survivors

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months/12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months/12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Program Acceptability

Program Feasibility

Secondary outcome measures

Adjuvant endocrine therapy (AET) Initiation

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,451 Total Patients Enrolled

Jamie M Jacobs, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment effort for participants in this trial?

"Per the details on clinicaltrials.gov, this medical trial is no longer recruiting participants - it was initially posted December 1st 2022 and last modified July 25th 2022. Fortunately, there are still 2,662 other trials actively seeking patients at present."

Answered by AI

Are there any studies utilizing this research protocol taking place within the North American region?

"This research project is presently recruiting patients from 4 distinct sites, such as Concord, Boston and Newton. If you decide to engage in this trial, it would be prudent to select the nearest site available to reduce travel demands."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Culturally Aware AET Non-Initiation Intervention

Jamie Jacobs 2022. "Culturally Aware AET Non-Initiation Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465408.