Community Health Workers and Precision Medicine

Not Applicable

Completed

• Conditions: Cancer; Tumor
• Interventions: Behavioral: Community Health Worker Support

• Registration Number: NCT04843332
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-13
• Study Start: 2021-05-03
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Health Worker Intervention	Community Health Worker Support	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.

Primary Outcome Measures

Name	Time	Method
Knowledge of precision medicine for cancer care	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 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 Outcome Measures

Name	Time	Method
Patient activation using the "Patient Activation Measure" survey	12-months post-enrollment	Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at enrollment and 12 months after study enrollment. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at 12 months after study enrollment.
Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"	6-months post-enrollment	Each patient will receive an adapted version of the 6-item Satisfaction with Decision Instrument at 6 months after study enrollment. Responses are "completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree," with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction. Minimum score is 9, maximum is 54. Responses for each group will be assessed at 3 months after study enrollment. The measure is adapted from: Holmes-Rovner, M., Kroll, J., Schmitt, N., Rovner, D. R., Breer, M. L., Rothert, M. L., ... \& Talarczyk, G. (1996). Patient satisfaction with health care decisions: the satisfaction with decision scale. Medical Decision Making, 16(1), 58-64.
7. Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"	12-months post-enrollment	Each patient will receive an adapted version of the 6-item Satisfaction with Decision Instrument at 12 months after study enrollment. Responses are "completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree," with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction. Minimum score is 9, maximum is 54. Responses for each group will be assessed at 3 months after study enrollment. The measure is adapted from: Holmes-Rovner, M., Kroll, J., Schmitt, N., Rovner, D. R., Breer, M. L., Rothert, M. L., ... \& Talarczyk, G. (1996). Patient satisfaction with health care decisions: the satisfaction with decision scale. Medical Decision Making, 16(1), 58-64.
Palliative Care Utilization (Chart Review)	12 months post-enrollment	Medical record review for quantity of use of any palliative care, any hospice, any chemotherapy, any radiotherapy, or any surgery.
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"	12 months post-enrollment	Each patient will the validated "Functional Assessment of Cancer Therapy - General Survey (FACT-G), " which is a 27-item survey with response options including: not at all, a little bit, somewhat, quite a bit, or very much. Five items also allow for a response of 'prefer not to answer.' Scoring for the FACT-G will be done in accordance with the FACT-G Scoring Guidelines (Version 4), available here: https://www.facit.org/measures-scoring-downloads/fact-g-scoring-downloads . In summary, scoring is for four subscales included within the survey, including (1) Physical Well-Being (score range: 0-28), (2) Social Family Well-Being (score range: 0-28), (3) Emotional Well-Being (score range: 0-24), and (4) Functional Well-Being (score range: 0-28). A total score is created from the sum of the subscale scores and has a minimum of zero and maximum of 108, where a higher score indicates greater quality of life. We will measure the change in quality of life at baseline to 12 months.
Prognosis & Treatment Preference	3 months post-enrollment	Patients will answer 4 multiple choice items to assess understanding of their prognosis and their treatment preferences. These items are not part of a named tool. They are adapted from the prognosis and treatment preference items developed by Weeks et al. (1998).; 1. Is your cancer curable? Response options (ROs): Yes, No, I don't know; 2. How long do most patients with your disease live on average? ROs: Less than 6 months, 6 months - 2 years, More than 2 years, I don't know; 3. The goal of my cancer treatment is to: (select all that apply) ROs: Cure my disease, help me feel better, extend my life, I don't know; 4. Would you prefer a course of treatment that focuses on extending life as much as possible, even if it means having more pain and discomfort, or would you want a plan of care that focuses on relieving pain and discomfort, even if that means not living as long? ROs: Extend life as much as possible, relieve pain or discomfort as much as possible, I don't know
Receipt of Molecular Profile and Genomic Testing	12 months post-enrollment	We will look at the percent of patients with receipt of molecular tumor profile and genomic testing (evidence-based treatment)
Emergency Department Visit (Chart Review)	12 months post-enrollment	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Hospitalization Visit (Chart Review)	12 months post-enrollment	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States