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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Fletcher Allen Health Care-Medical Center
Burlington, Vermont, United States
Optimal usage of AHT (includes initiation, continuation and adherence)
Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.
Time frame: Up to 3 months
Acceptance assessed via medical records of receiving a prescription for AHT and filling it
Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.
Time frame: Up to 3 months
Continuation assessed via self-report of taking at least one dose per week
Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.
Time frame: Up to 3 months
Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week
Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance. Weekly compliance (number of days reported taking medication) via the text messaging system will be examined longitudinally to assess whether a change over time was observed.
Time frame: Up to 3 months
Change in biomarkers
Comparisons (correlations, bivariate plots) will be made between the biomarkers and self-reported rates of usage to explore the feasibility of using a biomarker to measure optimal usage in future studies.
Time frame: Baseline to 3 months
Patient and physician responses to the intervention and study participation
Descriptive statistics will be generated.
Time frame: 3 months
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