Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients With Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 64
Summary
- Conditions
- Stage 0 Breast Cancer
- 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
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT02400060
- Collaborators
- Alliance for Clinical Trials in Oncology
- Investigators
- Principal Investigator: Michelle Naughton Ohio State University Comprehensive Cancer Center