Clinical trial NCT04843332: Community Health Workers and Precision Medicine
Official title: Reducing Cancer Disparities Through Innovative Community-Academic Partnership to Advance Access and Delivery of Precision Medicine in Monterey County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Tumor
Keywords: Precision medicine
Cancer care
lay health worker
community health worker
cancer treatment
patient satisfaction
palliative care
cancer diagnosis
quality of care
tumor testing
End-of-life
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: California Initiative to Advance Precision Medicine
name: Pacific Cancer Care
name: The Latino Cancer Institute
name: Cancer Patients Alliance
First posted: 2021-04-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a parallel two-arm randomized controlled trial with the following two arms: (1) usual oncology care or (2) usual oncology care + supplemental community health worker intervention. All participants who consent to the study will be randomized 1:1 into the usual oncology care arm versus the intervention arm. Patients randomized into the intervention arm will be assigned a community health worker who will begin the intervention. Each arm will include 55 participants (total for the study n=110).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in knowledge of precision medicine for cancer care from time of enrollment to 3 months post-enrollment
timeFrame: Time of Enrollment to 3-months post-enrollment
measure: Knowledge of precision medicine for cancer care
timeFrame: 6-months post-enrollment
measure: Knowledge of precision medicine for cancer care
timeFrame: 12-months post-enrollment
Secondary outcomes:
measure: Patient activation using the "Patient Activation Measure" survey
timeFrame: 3-months post-enrollment
measure: Patient activation using the "Patient Activation Measure" survey
timeFrame: 6-months post-enrollment
measure: Patient activation using the "Patient Activation Measure" survey
timeFrame: 12-months post-enrollment
measure: Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
timeFrame: 3-months post-enrollment
measure: Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
timeFrame: 6-months post-enrollment
measure: 7. Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
timeFrame: 12-months post-enrollment
measure: Palliative Care Utilization (Chart Review)
timeFrame: 12 months post-enrollment
measure: Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
timeFrame: Time of enrollment to 3-months post-enrollment
measure: Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
timeFrame: 6 months post-enrollment
measure: Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
timeFrame: 12 months post-enrollment
measure: Prognosis & Treatment Preference
timeFrame: 6 months post-enrollment
measure: Prognosis & Treatment Preference
timeFrame: 12 months post-enrollment
measure: Prognosis & Treatment Preference
timeFrame: 3 months post-enrollment
measure: Receipt of Molecular Profile and Genomic Testing
timeFrame: 12 months post-enrollment
measure: Emergency Department Visit (Chart Review)
timeFrame: 12 months post-enrollment
measure: Hospitalization Visit (Chart Review)
timeFrame: 12 months post-enrollment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
citation: Davies G, Butow P, Napier CE, Bartley N, Juraskova I, Meiser B, Ballinger ML, Thomas DM, Schlub TE, Best MC; members of the PiGeOn Project. Advanced Cancer Patient Knowledge of and Attitudes towards Tumor Molecular Profiling. Transl Oncol. 2020 Sep;13(9):100799. doi: 10.1016/j.tranon.2020.100799. Epub 2020 May 22.
citation: Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.
citation: Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J, Phillips RS. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA. 1998 Jun 3;279(21):1709-14. doi: 10.1001/jama.279.21.1709.
citation: Rodriguez GM, Wood EH, Xiao L, Duron Y, O'Brien D, Koontz Z, Rosas LG, Patel MI. Community health workers and precision medicine: A randomized controlled trial. Contemp Clin Trials. 2022 Oct;121:106906. doi: 10.1016/j.cct.2022.106906. Epub 2022 Sep 6.