Breast CarcinomaNCT04902144

Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

A study testing Electronic Health Record Review, Questionnaire Administration and Behavioral Intervention in people with Breast Carcinoma and Colon Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm
What is being tested?: Electronic Health Record Review, Questionnaire Administration and Behavioral Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2020to 31 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Medical oncology providers at OMC who see patients with an active diagnosis of breast, ovarian, prostate, colon, or pancreatic cancer

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Olympic Medical Cancer Center
Sequim, Washington, 98382

Other trials in United States

About this study

Official title: Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Read the 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.

Conditions: Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
Being tested: Electronic Health Record Review, Questionnaire Administration, Behavioral Intervention
Medical subject headings: Breast Neoplasms, Colonic Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electronic Health Record ReviewOther
Medical data collected
Questionnaire AdministrationOther
Complete questionnaires
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Receive coaching

Study groups in NCT04902144
Study group	Role	What they receive
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. Receives: Other: Electronic Health Record Review; Other: Questionnaire Administration; Behavioral: Behavioral Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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
Measured: Up to study completion (Assessed up to 1 year and 4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 202031 Dec 2021

First posted26 May 2021
Study start3 Aug 2020
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CarcinomaStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe 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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04902144
Sponsor's protocol ID: RG1121550
Other IDs: NCI-2021-04181, STUDY00010137, P30CA015704
Status last verified: May 2023
First submitted: 17 May 2021
Last updated: 9 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
ClinicalTrials.gov ID: NCT04902144
Acronym / sponsor ID: RG1121550
Conditions: Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 3 Aug 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 26 May 2021 (actual)
Results: Posted 9 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PHASE I: Patients' medical data are collected; no intervention.

OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Screening (medical records, coaching)	Experimental	Other: Electronic Health Record Review, Other: Questionnaire Administration, Behavioral: Behavioral InterventionPHASE 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.

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Medical oncology providers at OMC who see patients with an active diagnosis of breast, ovarian, prostate, colon, or pancreatic cancer

Key exclusion criteria (3 listed)

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)

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
Electronic Health Record ReviewMedical data collected	Other	Screening (medical records, coaching)
Questionnaire AdministrationComplete questionnaires	Other	Screening (medical records, coaching)
Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyReceive coaching	Behavioural	Screening (medical records, coaching)

Primary outcome

Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing
Time frame: 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
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 9 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medical Data Collection, Peer Coaching	6	6

Primary outcome: Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing

Time frame: 6 months. Number. Unit: patients

Measure	Medical Data Collection Without Peer Coaching n = 6	Medical Data Collection With Peer Coaching n = 6
Value	100	48

Primary outcome: Uptake of Genetic Testing

Time frame: Up to study completion (Assessed up to1 year and 4 months). Number. Unit: tests

Measure	Medical Data Collection Without Peer Coaching n = 415	Medical Data Collection With Peer Coaching n = 219
Value	29	25

Population analysed: The number of genetic testing kits ordered and processed for patients with cancer who meet criteria for testing in phase I and phase II

Primary outcome: Clinical and Patient Reported Outcomes Following Genetic Test Results

Time frame: Up to study completion (Assessed up to 1 year and 4 months). Count of participants. Unit: Participants

Measure	Medical Data Collection Without Peer Coaching n = 415	Medical Data Collection With Peer Coaching n = 219
Value	2	3

Population analysed: 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.

Adverse events

Time frame: Adverse events were not collected for this study. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening (Medical Records, Coaching)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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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.

Marianne Dubard-Gault principal investigator

Fred Hutch/University of Washington Cancer Consortium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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 9 Jun 2023. 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?

Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing (time frame: 6 months). 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 NCT04902144.

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 9 Jun 2023.