Clinical trial · Interventional
Community Health Workers and Precision Medicine
Reducing Cancer Disparities Through Innovative Community-Academic Partnership to Advance Access and Delivery of Precision Medicine in Monterey County
NCT04843332CI-TRIAL-00087357completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Community Health Worker Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Oncology Care
- description
- 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.
- type
- EXPERIMENTAL
- label
- Community Health Worker Intervention
- description
- 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.
- interventionNames
- Behavioral: Community Health Worker Support
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDDavies 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. PMID 32450551
- BACKGROUNDHolmes-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. PMID 8717600
- BACKGROUNDWeeks 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. PMID 9624023
- DERIVEDWood EH, Guzman LL, Reynaga JL, Villicana G, Duron Y, Rosas LG, O'Brien D, Koontz ZM, Patel MI. Community Health Workers and Precision Medicine: Results of a Randomized Clinical Trial on Patient Knowledge, Healthcare Use, and Evidence-Based Care. Cancers (Basel). 2026 Apr 14;18(8):1247. doi: 10.3390/cancers18081247. PMID 42073572
- DERIVEDRodriguez 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. PMID 36084898