A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Estrogen Receptor Positive Tumor
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Progesterone Receptor Positive Tumor
- Prognostic Stage IIA Breast Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04086875
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kuang-Yi Wen, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
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