NCT04086875

A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer

A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.

Detailed description

PRIMARY OBJECTIVES: I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design. SECONDARY OBJECTIVES: I. Conduct mediator analyses of intervention efficacy.. EXPLORATORY OBJECTIVES: I. Explore whether age (=\< 45 versus \[vs.\] \> 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress. OUTLINE: PHASE I: Participants attend focus groups on adherence to hormone therapy. PHASE II: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence. GROUP II: Participants receive usual care. After completion of study, participants are followed up at 3, 6, and 12 months.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Estrogen Receptor Positive Tumor
• Progesterone Receptor Positive Tumor
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8

Interventions

Type	Name	Description
BEHAVIORAL	Focus Group	Participate in focus group
OTHER	Text Message	Receive text messages
OTHER	Best Practice	Receive usual care
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-11-07
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2019-09-12
• Last updated: 2024-06-10

Locations

7 sites across 1 country: United States