Reducing Cancer Disparities Through Innovative Community-Academic Partnership to Advance Access and Delivery of Precision Medicine in Monterey County
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Knowledge of precision medicine for cancer care
研究概览
简要总结
The purpose of this randomized controlled trial is to evaluate whether a trained community health worker (CHW) who engages with newly diagnosed patients after a diagnosis of cancer can effectively improve knowledge and receipt of evidence-based precision medicine cancer care services among low-income and minority patients.
详细描述
The goal of this study is to reduce cancer disparities by improving the knowledge and delivery of evidence-based precision medicine for cancer care. We plan to randomize newly diagnosed patients and those currently under cancer care to either a control arm (usual cancer care alone) versus an intervention arm (layered on top of usual cancer care alone) where patients are assigned to a community health worker who will assist patients in ensuring the following discussions with their care team: 1) precision cancer care 2) cancer diagnosis and treatment plan 2) adherence to treatments and 3) goals of care and symptom burden. A total of 55 participants per study group (total 110) will be recruited in Monterey County from Pacific Cancer Care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with a cancer diagnosis.
- •Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by a physician.
- •The patients must be 18 years or older.
- •Patients must have the capacity to verbally consent in English or Spanish.
- •Patients must be racial/ethnic minorities OR low-income status OR public insurance (Medi-Cal or other) OR have health insurance provided by an agricultural company OR be uninsured
排除标准
- •Patients under 18 years of age.
- •Inability to consent to the study due to lack of capacity as documented by the referring physician.
- •Patients without a newly diagnosed malignancy or patients without relapse of disease.
研究组 & 干预措施
Usual Oncology Care
This arm is the control group. They will receive usual oncology care from their regular oncologist and care team with no change in their care plan or treatment as a result of the intervention. Outcomes will be assessed at each of the following times: baseline, 3-months, 6-months, and 12-months.
Community Health Worker Intervention
This arm is the treatment group. Patients randomized into the intervention will be assigned a community health worker who will contact the patient to begin the intervention. They will receive usual oncology care from their regular oncologist and care team but will also receive supplemental support and health education from a community health worker. The lay health worker will assist patients in ensuring that patients discuss the following with their cancer care teams: 1) precision medicine 2) cancer diagnosis and treatment plan 3) adherence to treatments and 3) goals of care and 4) symptom burden. Outcomes will be assessed at each of the following times: baseline, 3-months, 6-months, and 12-months.
干预措施: Community Health Worker Support (Behavioral)
结局指标
主要结局
Knowledge of precision medicine for cancer care
时间窗: 12-months post-enrollment
Using 7 multiple choice items adapted from an 8-item survey tool, Knowledge and Purpose of Molecular Profiling, by Davies et. al., 2020, we will assess knowledge of precision medicine (molecular profiling and tumor testing) for cancer care. All questions are multiple choice. For example one question asks 'tumor testing is helpful for making decisions about future cancer risks,' with answer choices: always, frequently, sometimes, rarely, never, or I don't know. Answers will be scored as number or percent correct. Adapted from the following paper: Davies, G., Butow, P., Napier, C. E., Bartley, N., Juraskova, I., Meiser, B., ... \& Best, M. C. (2020). Advanced Cancer Patient Knowledge of and Attitudes towards Tumor Molecular Profiling. Translational Oncology, 13(9), 100799.
Change in knowledge of precision medicine for cancer care from time of enrollment to 3 months post-enrollment
时间窗: Time of Enrollment to 3-months post-enrollment
Using 7 multiple choice items adapted from an 8-item survey tool, Knowledge and Purpose of Molecular Profiling, by Davies et. al., 2020, we will assess knowledge of precision medicine (molecular profiling and tumor testing) for cancer care. All questions are multiple choice. For example one question asks 'tumor testing is helpful for making decisions about future cancer risks,' with answer choices: always, frequently, sometimes, rarely, never, or I don't know. Answers will be scored as number or percent correct. Adapted from the following paper: Davies, G., Butow, P., Napier, C. E., Bartley, N., Juraskova, I., Meiser, B., ... \& Best, M. C. (2020). Advanced Cancer Patient Knowledge of and Attitudes towards Tumor Molecular Profiling. Translational Oncology, 13(9), 100799.
次要结局
- Patient activation using the "Patient Activation Measure" survey(12-months post-enrollment)
- Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"(6-months post-enrollment)
- 7. Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"(12-months post-enrollment)
- Palliative Care Utilization (Chart Review)(12 months post-enrollment)
- Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"(12 months post-enrollment)
- Prognosis & Treatment Preference(3 months post-enrollment)
- Receipt of Molecular Profile and Genomic Testing(12 months post-enrollment)
- Emergency Department Visit (Chart Review)(12 months post-enrollment)
- Hospitalization Visit (Chart Review)(12 months post-enrollment)
研究者
Manali Indravadan Patel
Assistant Professor of Medicine
Stanford University