Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- Medication adherence
研究概览
简要总结
This is an intervention targeting patients at risk for non-adherence to endocrine therapy after primary treatments for hormone-positive breast cancer. In a randomized study, the study team will collect patient-reported symptoms monthly from participants through surveys. Pharmacists who specialize in cancer at the patients' hospital will give patients recommendations to help improve their symptoms and address other barriers so they can continue daily endocrine therapy medications.
详细描述
This study will test whether oncology teams can adapt and combine models from intensive oncologic care and chronic noncancer care to support long-term oral oncologic medication adherence through better symptom monitoring and management. It will identify patients at risk of nonadherence through electronic health records and target them with a symptom monitoring and management intervention. The study will use patient-reported outcomes (PROs) to identify symptoms that may cause nonadherence and will involve clinical pharmacist-led follow-up.
Objectives:
- Assess the impact of the intervention on adherence to oral endocrine therapy.
- Evaluate the durability of adherence one-year post-intervention.
- Describe the impact on symptoms and explore mechanisms for adherence improvement.
Intervention:
During the intervention phase, patients will receive symptom monitoring and pharmacist-led management based on patient-reported outcomes (PROs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician will be blinded for outcomes assessment for the 12-month outcomes.
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
- •Cisgender women assigned female at birth
- •Age 18 years or older
- •Stage 1-3 hormone receptor-positive breast cancer
- •Premenopausal patients being treated with GNRH agonist/antagonist to induce menopause are eligible
- •Patients who received treatment with CDK 4/6 inhibitors are eligible
- •Recommended to continue AET for ≥2 additional years after enrollment
- •Low adherence defined as prescription fills with a proportion of days covered (PDC) of <80%, examined over all fills during the 2 years prior to date of eligibility review since the first AET prescription/data of AET start OR unable to calculate adherence
- •Verbal fluency in English or Spanish
- •Ability to understand informed consent and the willingness to sign it
排除标准
- •Unable to verbalize comprehension of study or impaired decision-making
- •Known distant metastatic disease
- •Not receiving breast cancer care or AET prescription from provider at participating site
- •Evidence that an oncology provider discontinued their AET
- •Pregnant or trying to get pregnant
- •Facility-administered medications (i.e., nursing home, home healthcare agency)
结局指标
主要结局
Medication adherence
时间窗: From baseline to 12 months
Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap
Intervention durability on medication adherence
时间窗: From 12 to 24 months
Assess the durability of AET adherence 1 year post intervention on patients assigned to the intervention phase first. Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap
次要结局
- Medication adherence(From baseline to 12 months)
- Pain(From baseline to 24 months)
- Fatigue(From baseline to 24 months)
- Sleep(From baseline to 24 months)
- Anxiety(From baseline to 24 months)
- Depression(From baseline to 24 months)
- Sexual function(From baseline to 24 months)
- Physical functioning(From baseline to 24 months)
- Social functioning(From baseline to 24 months)
- Self-efficacy to manage medications(From baseline to 24 months)
- Self-efficacy to manage symptoms(From baseline to 24 months)
- Social support(From baseline to 24 months)
- Team-patient communication quality(From baseline to 12 months)
研究者
Kathryn Flynn
Vice Chair, Professor
Medical College of Wisconsin