Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERElectronic Health Record Review
Medical data collected
OTHERQuestionnaire Administration
Complete questionnaires
BEHAVIORALBehavioral Intervention
Receive coaching
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Medical oncology providers at OMC who see patients with an active diagnosis of breast, ovarian, prostate, colon, or pancreatic cancer
Exclusion criteria
* OMC providers who do not see patients with an active diagnosis of cancer * OMC providers who see patients who are minors * OMC providers who see patients with precancerous lesions such as ductal carcinoma in situ (the presence of abnormal cells inside a milk duct in the breast) or colon polyps (a small clump of cells that form on the lining of the colon or rectum)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing | 6 months | The number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers |
| Uptake of Genetic Testing | Up to study completion (Assessed up to1 year and 4 months) | 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. |
| Clinical and Patient Reported Outcomes Following Genetic Test Results | Up to study completion (Assessed up to 1 year and 4 months) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Medical Data Collection, Peer Coaching |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 55 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: Up to study completion (Assessed up to 1 year and 4 months)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Data Collection Without Peer Coaching | Clinical and Patient Reported Outcomes Following Genetic Test Results | 2 Participants |
| Medical Data Collection With Peer Coaching | Clinical and Patient Reported Outcomes Following Genetic Test Results | 3 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Data Collection Without Peer Coaching | Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing | 100 patients |
| Medical Data Collection With Peer Coaching | Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing | 48 patients |
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.
Time frame: Up to study completion (Assessed up to1 year and 4 months)
Population: The number of genetic testing kits ordered and processed for patients with cancer who meet criteria for testing in phase I and phase II
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Data Collection Without Peer Coaching | Uptake of Genetic Testing | 29 tests |
| Medical Data Collection With Peer Coaching | Uptake of Genetic Testing | 25 tests |