- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04843332
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Oncology Care
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.
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Experimental: Community Health Worker 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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Knowledge of precision medicine for cancer care
Time Frame: 6-months post-enrollment
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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
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Knowledge of precision medicine for cancer care
Time Frame: 12-months post-enrollment
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient activation using the "Patient Activation Measure" survey
Time Frame: 3-months post-enrollment
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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.
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3-months post-enrollment
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Patient activation using the "Patient Activation Measure" survey
Time Frame: 6-months post-enrollment
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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.
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6-months post-enrollment
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Patient activation using the "Patient Activation Measure" survey
Time Frame: 12-months post-enrollment
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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.
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12-months post-enrollment
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Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Time Frame: 3-months post-enrollment
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Each patient will receive the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) 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.
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3-months post-enrollment
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Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Time Frame: 6-months post-enrollment
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Each patient will receive the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) 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 6 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.
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6-months post-enrollment
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Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Time Frame: 12-months post-enrollment
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Each patient will receive the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) 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 12 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.
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12-months post-enrollment
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Palliative Care Utilization (Chart Review)
Time Frame: 3 months post-enrollment
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Medical record review for quantity of use of any palliative care, any hospice, any chemotherapy, any radiotherapy, or any surgery.
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3 months post-enrollment
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Palliative Care Utilization (Chart Review)
Time Frame: 6 months post-enrollment
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Medical record review for quantity of use of any palliative care, any hospice, any chemotherapy, any radiotherapy, or any surgery.
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6 months post-enrollment
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Palliative Care Utilization (Chart Review)
Time Frame: 12 months post-enrollment
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Medical record review for quantity of use of any palliative care, any hospice, any chemotherapy, any radiotherapy, or any surgery.
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12 months post-enrollment
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Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Time Frame: Time of enrollment to 3-months post-enrollment
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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.
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Time of enrollment to 3-months post-enrollment
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Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Time Frame: 6 months post-enrollment
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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.
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6 months post-enrollment
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Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Time Frame: 12 months post-enrollment
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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.
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12 months post-enrollment
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Prognosis & Treatment Preference
Time Frame: 6 months post-enrollment
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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).
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6 months post-enrollment
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Prognosis & Treatment Preference
Time Frame: 12 months post-enrollment
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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).
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12 months post-enrollment
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Prognosis & Treatment Preference
Time Frame: 3 months post-enrollment
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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).
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3 months post-enrollment
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Receipt of Molecular Profile and Genomic Testing
Time Frame: 12 months post-enrollment
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We will look at the percent of patients with receipt of molecular tumor profile and genomic testing (evidence-based treatment)
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12 months post-enrollment
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Emergency Department Visit (Chart Review)
Time Frame: 3 months post-enrollment
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Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 3 months after enrollment.
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3 months post-enrollment
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Emergency Department Visit (Chart Review)
Time Frame: 6 months post-enrollment
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Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
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6 months post-enrollment
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Emergency Department Visit (Chart Review)
Time Frame: 12 months post-enrollment
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Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
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12 months post-enrollment
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Hospitalization Visit (Chart Review)
Time Frame: 3 months post-enrollment
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Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 3 months after enrollment.
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3 months post-enrollment
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Hospitalization Visit (Chart Review)
Time Frame: 6 months post-enrollment
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Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
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6 months post-enrollment
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Hospitalization Visit (Chart Review)
Time Frame: 12 months post-enrollment
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Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
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12 months post-enrollment
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: JAMA 2000 Jan 12;283(2):203.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 59885
- OPR18113 (Other Grant/Funding Number: California Initiative to Advance Precision Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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