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Hormone Therapy

Telephone Support for Breast Cancer Treatment Adherence

Q: Are new participants being accepted into this research project?

<p>This clinical trial is currently enrolling participants, according to information shared on clinicaltrials.gov. The post date was March 26th 2014 and the most recent edit occured October 27th 2022.</p>

Q: What is the current participant count for this clinical trial?

<p>Affirmative. The information on clinicaltrials.gov notes that this medical research, which was initially made public on March 26th 2014, is actively recruiting participants. Specifically, it requires 314 subjects from 2 distinct healthcare facilities.</p>

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

Study 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.Check my eligibility

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.See study design

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).

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

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

Primary outcome measures

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 outcome measures

Change in biomarkers

Patient and physician responses to the intervention and study participation

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyOTHER

512 Previous Clinical Trials

217,324 Total Patients Enrolled

75 Trials studying Breast Cancer

40,143 Patients Enrolled for Breast Cancer

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

289,853 Total Patients Enrolled

22 Trials studying Breast Cancer

2,884 Patients Enrolled for Breast Cancer

Michelle NaughtonPrincipal 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

Frequently Asked Questions

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

Are new participants being accepted into this research project?

"This clinical trial is currently enrolling participants, according to information shared on clinicaltrials.gov. The post date was March 26th 2014 and the most recent edit occured October 27th 2022."

Answered by AI

What is the current participant count for this clinical trial?

"Affirmative. The information on clinicaltrials.gov notes that this medical research, which was initially made public on March 26th 2014, is actively recruiting participants. Specifically, it requires 314 subjects from 2 distinct healthcare facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients With Breast Cancer

Michelle Naughton 2014. "Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02400060.

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