CancerNCT04843332
Community Health Workers and Precision Medicine
A study testing Community Health Worker Support in people with Cancer and Tumor, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Community Health Worker Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Cancer Disparities Through Innovative Community-Academic Partnership to Advance Access and Delivery of Precision Medicine in Monterey County
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.
Read the 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.
- Being tested
- Community Health Worker Support
- 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
- Medical subject headings
- Neoplasms, Patient Satisfaction, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Health Worker Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12-months post-enrollment
Secondary outcomes (16)
Patient activation using the "Patient Activation Measure" survey
Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at enrollment and 3 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 3 months after study enrollment.
Measured: 3-months post-enrollment
Patient activation using the "Patient Activation Measure" survey
Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at enrollment and 6 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 6 months after study enrollment.
Measured: 6-months post-enrollment
Patient activation using the "Patient Activation Measure" survey
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.
Measured: 12-months post-enrollment
Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
Each patient will receive an adapted version of the 6-item Satisfaction with Decision Instrument at 3 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.
Measured: 3-months post-enrollment
Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
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.
Measured: 6-months post-enrollment
7. Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
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.
Measured: 12-months post-enrollment
Palliative Care Utilization (Chart Review)
Medical record review for quantity of use of any palliative care, any hospice, any chemotherapy, any radiotherapy, or any surgery.
Measured: 12 months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
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 3 months.
Measured: Time of enrollment to 3-months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
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 6 months.
Measured: 6 months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
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.
Measured: 12 months post-enrollment
Prognosis & Treatment Preference
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).
- Is your cancer curable? Response options (ROs): Yes, No, I don't know
- 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
- 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
- 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
Measured: 6 months post-enrollment
Prognosis & Treatment Preference
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).
- Is your cancer curable? Response options (ROs): Yes, No, I don't know
- 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
- 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
- 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
Measured: 12 months post-enrollment
Prognosis & Treatment Preference
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).
- Is your cancer curable? Response options (ROs): Yes, No, I don't know
- 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
- 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
- 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
Measured: 3 months post-enrollment
Receipt of Molecular Profile and Genomic Testing
We will look at the percent of patients with receipt of molecular tumor profile and genomic testing (evidence-based treatment)
Measured: 12 months post-enrollment
Emergency Department Visit (Chart Review)
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Measured: 12 months post-enrollment
Hospitalization Visit (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Measured: 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start3 May 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- California Initiative to Advance Precision Medicine, Pacific Cancer Care, The Latino Cancer Institute, Cancer Patients Alliance
- Responsible party
- Principal investigator, Manali Indravadan Patel, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843332
- Sponsor's protocol ID
- 59885
- Other IDs
- OPR18113
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will not be shared with researchers outside of this project.
Publications
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.
PubMed 32450551Holmes-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.
PubMed 8717600Weeks 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.
PubMed 9624023Wood 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.
PubMed 42073572Rodriguez 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.
PubMed 36084898
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cancer Disparities Through Innovative Community-Academic Partnership to Advance Access and Delivery of Precision Medicine in Monterey County
- ClinicalTrials.gov ID
- NCT04843332
- Acronym / sponsor ID
- 59885
- Keywords
- Precision medicine, Cancer care, lay health worker, community health worker, cancer treatment, patient satisfaction, palliative care, cancer diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- California Initiative to Advance Precision Medicine, Pacific Cancer Care, The Latino Cancer Institute, Cancer Patients Alliance
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Community Health Worker SupportThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker SupportFor those in the experimental group, a community health worker will provide health education and support as described in the Community Health Worker Intervention arm. | Behavioural | Community Health Worker Intervention |
Primary outcome
Change in knowledge of precision medicine for cancer care from time of enrollment to 3 months post-enrollment
Time frame: 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.
Knowledge of precision medicine for cancer care
Time frame: 6-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.
Knowledge of precision medicine for cancer care
Time frame: 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.
16 secondary outcomes
Patient activation using the "Patient Activation Measure" survey
Time frame: 3-months post-enrollment
Patient activation using the "Patient Activation Measure" survey
Time frame: 6-months post-enrollment
Patient activation using the "Patient Activation Measure" survey
Time frame: 12-months post-enrollment
Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
Time frame: 3-months post-enrollment
Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
Time frame: 6-months post-enrollment
7. Patient Satisfaction With Decision measured with the "Satisfaction with Decision Instrument"
Time frame: 12-months post-enrollment
Palliative Care Utilization (Chart Review)
Time frame: 12 months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Time frame: Time of enrollment to 3-months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Time frame: 6 months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Time frame: 12 months post-enrollment
Prognosis & Treatment Preference
Time frame: 6 months post-enrollment
Prognosis & Treatment Preference
Time frame: 12 months post-enrollment
Prognosis & Treatment Preference
Time frame: 3 months post-enrollment
Receipt of Molecular Profile and Genomic Testing
Time frame: 12 months post-enrollment
Emergency Department Visit (Chart Review)
Time frame: 12 months post-enrollment
Hospitalization Visit (Chart Review)
Time frame: 12 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 32450551Davies 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.
- Background: PubMed 8717600Holmes-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.
- Background: PubMed 9624023Weeks 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.
- Derived from this study: PubMed 42073572Wood 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.
- Derived from this study: PubMed 36084898Rodriguez 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.
- Scoring Guide for FACT-GLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study data will not be shared with researchers outside of this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Support in people with Cancer and Tumor, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge of precision medicine for cancer care from time of enrollment to 3 months post-enrollment (time frame: Time of Enrollment to 3-months post-enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843332, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.