Community Health Workers and Precision Medicine

NCT04843332 | Completed

• 2 other identifiers: 59885OPR18113
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Change in knowledge of precision medicine for cancer care from 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.

  Time of Enrollment to 3-months post-enrollment

• Knowledge of precision medicine for cancer care

  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.

  6-months post-enrollment

• Knowledge of precision medicine for cancer care

  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.

  12-months post-enrollment

Secondary Outcomes (16)

• Patient activation using the "Patient Activation Measure" survey

  3-months post-enrollment

• Patient activation using the "Patient Activation Measure" survey

  6-months post-enrollment

• Patient activation using the "Patient Activation Measure" survey

  12-months post-enrollment

• Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"

  3-months post-enrollment

• Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"

  6-months post-enrollment

Study Arms (2)

Usual Oncology Care

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Community Health Worker Support

Interventions

Community Health Worker Support BEHAVIORAL

For those in the experimental group, a community health worker will provide health education and support as described in the Community Health Worker Intervention arm.

Community Health Worker Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• California Initiative to Advance Precision Medicine: collaborator
• Pacific Cancer Care: collaborator
• The Latino Cancer Institute: collaborator
• Cancer Patients Alliance: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (4)

• 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.

  PMID: 32450551 BACKGROUND

• 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.

  PMID: 8717600 BACKGROUND

• 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.

  PMID: 9624023 BACKGROUND

• 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.

  PMID: 36084898 DERIVED

Related Links

• Scoring Guide for FACT-G

MeSH Terms

Conditions

Neoplasms; Patient Satisfaction; Death

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: May 3, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)