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Behavioral Intervention

Community Health Worker Support for Cancer

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed patients with a cancer diagnosis.

Patients must have the capacity to verbally consent in English or Spanish.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-enrollment

Awards & highlights

Study Summary

This trial will test whether a community health worker can help low-income and minority patients get better cancer care.

Who is the study for?

This trial is for adults over 18 who've just been diagnosed with cancer. It's specifically aimed at helping low-income and minority patients, or those with public insurance, agricultural company-provided insurance, or no insurance at all. Patients must be able to consent in English or Spanish and have a confirmed diagnosis of new or relapsed cancer.Check my eligibility

What is being tested?

The study is testing if support from trained community health workers can boost understanding and use of precision medicine treatments in cancer care among disadvantaged groups. Participants are randomly assigned to receive this extra support or not.See study design

What are the potential side effects?

Since the intervention involves support from a community health worker rather than medical treatment, there are no direct side effects related to medications; however, participants may experience varying levels of emotional impact due to engagement about their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recently been diagnosed with cancer.

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I can give my consent in English or Spanish.

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My cancer has come back or gotten worse, as confirmed by tests.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months post-enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in knowledge of precision medicine for cancer care from time of enrollment to 3 months post-enrollment

Knowledge of precision medicine for cancer care

Secondary outcome measures

Emergency Department Visit (Chart Review)

Hospitalization Visit (Chart Review)

Palliative Care Utilization (Chart Review)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Community Health Worker InterventionExperimental Treatment1 Intervention

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.

Group II: Usual Oncology CareActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Community Health Worker Support

2021

N/A

~110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,940 Total Patients Enrolled

California Initiative to Advance Precision MedicineOTHER

4 Previous Clinical Trials

1,296 Total Patients Enrolled

Pacific Cancer CareUNKNOWN

Media Library

Community Health Workers (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04843332 — N/A

Cancer Research Study Groups: Usual Oncology Care, Community Health Worker Intervention

Cancer Clinical Trial 2023: Community Health Workers Highlights & Side Effects. Trial Name: NCT04843332 — N/A

Community Health Workers (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions in this experiment available to potential participants?

"Affirmative. Clinicaltrials.gov has verified that this clinical investigation, which was first made available on May 3rd 2021, is still accepting applications from potential participants. 110 volunteers are to be enlisted across one medical facility for the duration of the study."

Answered by AI

What is the current participant count in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this experiment is currently recruiting patients, having been initially posted on May 3rd 2021 and updated as recently as February 8th 2022. The study requires 110 volunteers across a single medical centre to participate in the trial."

Answered by AI

What is the primary objective of this clinical experiment?

"The primary goal of this medical trial, monitored from the time of enrolment to 3 months post-enrolment is assessing understanding and utilization of precision medicine for cancer management. Secondary objectives involve surveying patient satisfaction with shared decision making (using a 9-item questionnaire) and quality of life evaluation (with FACT-G survey), as well as reviewing palliative care utilisation records in order to gauge clinical efficacy."

Answered by AI

Recent research and studies

Translational OncologyJournal

Advanced Cancer Patient Knowledge of and Attitudes Towards Tumor Molecular Profiling

Davies, Grace, Phyllis Butow, Christine E. Napier, Nicci Bartley, Ilona Juraskova, Bettina Meiser, Mandy L. Ballinger, David M. Thomas, Timothy E. Schlub, and Megan C. Best. 2020. “Advanced Cancer Patient Knowledge of and Attitudes Towards Tumor Molecular Profiling”. Translational Oncology. Elsevier BV. doi:10.1016/j.tranon.2020.100799.

Medical Decision MakingJournal

Patient Satisfaction with Health Care Decisions

Holmes-Rovner, Margaret, Jill Kroll, Neal Schmitt, David R. Rovner, M. Lynn Breer, Marilyn L. Rothert, Georgia Padonu, and Geraldine Talarczyk. 1996. “Patient Satisfaction with Health Care Decisions”. Medical Decision Making. SAGE Publications. doi:10.1177/0272989x9601600114.

JamaJournal

Relationship Between Cancer Patients' Predictions of Prognosis and Their Treatment Preferences

Weeks, Jane C.. 1998. “Relationship Between Cancer Patients' Predictions of Prognosis and Their Treatment Preferences”. Jama. American Medical Association (AMA). doi:10.1001/jama.279.21.1709.

Contemporary Clinical TrialsJournal