NCT02400060

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

Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies a telephone-based intervention to see if it increases adherence to adjuvant hormonal therapy in patients with breast cancer. Increasing communication between doctors and patients with breast cancer may help patients to better follow recommendations on taking adjuvant hormonal treatment medication. A telephone-based intervention may help to increase doctor-patient communication and patients' adherence to their prescribed medication.

Detailed description

PRIMARY OBJECTIVES: I. Pilot test intervention effects on adherence to adjuvant hormonal therapy (AHT) and explore trends in the adherence outcomes by demographic and psychosocial factors defined as acceptance, continuation, and adherence. SECONDARY OBJECTIVES: I. Feasibility of study design defined as recruitment rate, rate of using intervention as instructed, rate of protocol completion, and completion of psycho-social questionnaires which have been associated with adherence to AHT in the existing literature (i.e., depression, social support, pain, stress, fatigue, quality of life, pill taking attitude and behavior, perceived risk of breast cancer recurrence). TERTIARY OBJECTIVES: I. Surveying patients and physicians regarding their comments on the intervention components (i.e., video, text messaging, and app \[application\]) and overall study participation. OUTLINE: Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.

Conditions

• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage 0 Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Telephone-Based Intervention	Receive text messaging
OTHER	Survey Administration	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2015-03-26
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2015-03-26
• Last updated: 2025-06-29

Locations

4 sites across 1 country: United States