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Hormone Therapy

Text-based Intervention for Breast Cancer

N/A
Waitlist Available
Led By Kuang-Yi Wen, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed local definitive treatment (i.e., surgery chemotherapy, radiation)
Woman diagnosed with stage I-III breast cancer (BCa)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a text-based intervention to improve adherence to hormone therapy in patients with hormone receptor positive breast cancer.

Who is the study for?
This trial is for women within 3 months of starting a new hormone therapy after being diagnosed with stage I-III hormone receptor positive breast cancer. Participants must be recommended to undergo at least 12 months of therapy, know how to text or willing to learn, have completed their initial treatments like surgery and chemotherapy, understand English, consent to the study, and own a mobile device that can send texts.
What is being tested?
The trial is testing whether sending educational text messages can help women stick to their long-term hormone therapy regimen for early-stage breast cancer. It aims to see if this support improves adherence when side effects might otherwise discourage them from continuing treatment.
What are the potential side effects?
While the intervention itself (text messaging) does not have direct side effects, it's important to note that the hormone therapies being adhered to may cause symptoms such as hot flashes, fatigue, mood changes, decreased sex drive and joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished all my initial cancer treatments.
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I am a woman with stage I-III breast cancer.
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I have been advised to undergo hormone therapy for at least 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Adjuvant hormone therapy (AHT) adherence
Symptom distress
Secondary study objectives
Cognitive-affective barriers for AHT adherence
Cognitive-affective barriers for symptom distress
Other study objectives
Affective Disorders, Psychotic
Knowledge and self-efficacy for taking AHT
Perceived benefits
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase II Group 1 (text messages)Experimental Treatment2 Interventions
Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
Group II: Phase 1 (focus groups)Experimental Treatment2 Interventions
Participants attend focus groups on adherence to hormone therapy.
Group III: Phase II Group II (usual care)Active Control2 Interventions
Participants receive usual care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focus Group
2017
Completed Phase 1
~4710

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,838 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,257 Patients Enrolled for Breast Cancer
Thomas Jefferson UniversityLead Sponsor
464 Previous Clinical Trials
175,417 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
Kuang-Yi Wen, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Text-based Intervention (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04086875 — N/A
Breast Cancer Research Study Groups: Phase II Group II (usual care), Phase II Group 1 (text messages), Phase 1 (focus groups)
Breast Cancer Clinical Trial 2023: Text-based Intervention Highlights & Side Effects. Trial Name: NCT04086875 — N/A
Text-based Intervention (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086875 — N/A
~47 spots leftby Dec 2025
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