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Hormone Therapy

Telephone Support for Breast Cancer Treatment Adherence

N/A
Recruiting
Led By Michelle Naughton
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible women who are post-menopausal, verified by: post bilateral surgical oophorectomy; or no spontaneous menses >= 1 year; or no menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Diagnosed with primary breast cancer (BC) (stages I-III)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a telephone intervention to see if it increases adherence to adjuvant hormonal therapy in patients with breast cancer. The intervention may help to increase doctor-patient communication and patients' adherence to their prescribed medication.

Who is the study for?
This trial is for post-menopausal women with stages I-III breast cancer who've finished primary treatment and are starting adjuvant hormonal therapy (AHT) like tamoxifen or aromatase inhibitors. Participants must own a smartphone, agree to text communication, consent to medical record review, and plan to stay in the study area for at least 3 months.
What is being tested?
The study tests if regular phone calls can help patients stick to their hormone therapy schedule after breast cancer treatment. It involves surveys, lab biomarker analysis, and a telephone-based program designed to improve doctor-patient communication about medication adherence.
What are the potential side effects?
Since this trial focuses on a telephone-based intervention rather than a drug, there aren't direct side effects from medications being tested. However, participants may experience increased stress or anxiety due to frequent communication about their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am post-menopausal, confirmed by surgery, lack of periods for a year, or hormone levels.
Select...
I have been diagnosed with early-stage breast cancer (stages I-III).
Select...
I am eligible to start hormone therapy (tamoxifen or an AI) for the first time.
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I have finished all my initial cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptance assessed via medical records of receiving a prescription for AHT and filling it
Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week
Continuation assessed via self-report of taking at least one dose per week
+1 more
Secondary study objectives
Change in biomarkers
Patient and physician responses to the intervention and study participation

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: Supportive (text messages and interactive exchanges)Experimental Treatment3 Interventions
Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2017
Completed Phase 2
~3400

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyOTHER
518 Previous Clinical Trials
222,023 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Ohio State University Comprehensive Cancer CenterLead Sponsor
341 Previous Clinical Trials
292,866 Total Patients Enrolled
23 Trials studying Breast Cancer
2,902 Patients Enrolled for Breast Cancer
Michelle NaughtonPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Michelle Naughton, PhD, MPHPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Adjuvant Hormonal Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02400060 — N/A
Breast Cancer Research Study Groups: Supportive (text messages and interactive exchanges)
Breast Cancer Clinical Trial 2023: Adjuvant Hormonal Therapy Highlights & Side Effects. Trial Name: NCT02400060 — N/A
Adjuvant Hormonal Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02400060 — N/A
~0 spots leftby Dec 2024
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