Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 8
- 主要终点
- Acceptance assessed via medical records of receiving a prescription for AHT and filling it
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible women are those who:
- •Are post-menopausal, verified by:
- •Post bilateral surgical oophorectomy; or
- •No spontaneous menses >= 1 year; or
- •No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
- •Are diagnosed with primary breast cancer (BC) (stages I-III)
- •Eligible to receive AHT (tamoxifen or an aromatase inhibitors [AI]) for the first time
- •Completed all primary treatment
- •Own a smartphone (in order to receive text messages and utilize the phone app)
- •Agree to receive text messages on their smartphone over a 3-month period
- •Provide consent and permission to review their medical records
- •Plan to stay in the study area for 3 months
排除标准
- 未提供
结局指标
主要结局
Acceptance assessed via medical records of receiving a prescription for AHT and filling it
时间窗: Up to 3 months
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.
Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week
时间窗: Up to 3 months
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.
Optimal usage of AHT (includes initiation, continuation and adherence)
时间窗: Up to 3 months
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.
Continuation assessed via self-report of taking at least one dose per week
时间窗: Up to 3 months
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.
次要结局
- Change in biomarkers(Baseline to 3 months)
- Patient and physician responses to the intervention and study participation(3 months)
研究者
Michelle Naughton
Principal Investigator
Ohio State University Comprehensive Cancer Center