Reducing Cancer Disparities Through Innovative Community-Academic Partnership to Advance Access and Delivery of Precision Medicine in Monterey County
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Stanford University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Knowledge of precision medicine for cancer care
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Manali Indravadan Patel
Assistant Professor of Medicine
Stanford University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Knowledge of precision medicine for cancer care
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)