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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-04181 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00010137 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical quality improvement study reviews and develops a clinical operations workflow to identify cancer patients who meet criteria for genetic counseling and testing. This study may improve utilization of genetic counseling and testing amongst community-based oncology providers caring for cancer patients in a rural and underserved area.
OUTLINE: Medical oncologists at Olympic Medical Center (OMC) participated in this study and received a peer coaching intervention during phase II to help identify patients who meet criteria for genetic counseling and testing
PHASE I: Patients' medical data are collected; no intervention.
PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.
OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (medical records, coaching) | Experimental | PHASE I: Patients' medical data are collected. PHASE II: Patients complete questionnaires and their medical data is collected. SCCA subject matter experts and OMC providers review patients' medical data at bi-monthly virtual conferences. OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Medical data collected |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing | The number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers | 6 months |
| Uptake of Genetic Testing | Number of genetic testing ordered and processed for patients with cancer who meet criteria for testing. Out of 415 patients seen in phase I, 100 met criteria but only 29 received testing. Out of 219 patients seen in phase II, 48 met criteria but only 25 received testing. | Up to study completion (Assessed up to1 year and 4 months) |
| Clinical and Patient Reported Outcomes Following Genetic Test Results | Pertinent clinical information regarding genetic test result and related outcomes (referrals, treatment recommendations); pulled directly from electronic health record, genetic test reports, and patient questionnaires | Up to study completion (Assessed up to 1 year and 4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Dubard-Gault | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olympic Medical Cancer Center | Sequim | Washington | 98382 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Data Collection, Peer Coaching | PHASE I: Patients' medical data are collected, PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing. OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients. Electronic Health Record Review: Medical data collected Questionnaire Administration: Complete questionnaires |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2020 | May 12, 2023 |
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| Questionnaire Administration |
| Other |
Complete questionnaires |
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| Behavioral Intervention | Behavioral | Receive coaching |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Medical Data Collection, Peer Coaching | PHASE I: Patients' medical data are collected, PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing. OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients. Electronic Health Record Review: Medical data collected Questionnaire Administration: Complete questionnaires |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing | The number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers | Posted | Number | patients | 6 months |
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| ||||||||||||||||||||||||||||||
| Primary | Uptake of Genetic Testing | Number of genetic testing ordered and processed for patients with cancer who meet criteria for testing. Out of 415 patients seen in phase I, 100 met criteria but only 29 received testing. Out of 219 patients seen in phase II, 48 met criteria but only 25 received testing. | The number of genetic testing kits ordered and processed for patients with cancer who meet criteria for testing in phase I and phase II | Posted | Number | tests | Up to study completion (Assessed up to1 year and 4 months) |
| |||||||||||||||||||||||||||||||
| Primary | Clinical and Patient Reported Outcomes Following Genetic Test Results | Pertinent clinical information regarding genetic test result and related outcomes (referrals, treatment recommendations); pulled directly from electronic health record, genetic test reports, and patient questionnaires | 5 patients were referred to our center for post test counseling and treatment recommendations in the setting of positive results. Many other patients could have chosen to go to a cancer genetic clinic closer to their home. | Posted | Count of Participants | Participants | Up to study completion (Assessed up to 1 year and 4 months) |
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Adverse events were not collected for this study
This study did peer coaching of medical oncologists as study participants. No patients were considered study participants. Adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening (Medical Records, Coaching) | PHASE I: Patients' medical data are collected. PHASE II: Patients complete questionnaires and their medical data is collected. SCCA subject matter experts and OMC providers review patients' medical data at bi-monthly virtual conferences. OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients. Electronic Health Record Review: Medical data collected Questionnaire Administration: Complete questionnaires Behavioral Intervention: Receive coaching | 0 | 0 | 0 | 0 | 0 | 0 |
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This study was not a clinical trial, it was a quality improvement project of practices of rural medical oncologists to increase their ordering of GT when indicated for their patients with active cancer. Six rural oncologists participated in both phases, the observation phase and the peer coaching phase, and and for the full length of QI study. Number of patients seen and number of tests ordered was collected to measure effectiveness of peer coaching. No data on adverse events were collected.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marianne Dubard-Gault | University of Washington | 206-606-6990 | mdg2019@uw.edu |
| Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2020 | Mar 27, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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