Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

NCT04902144 | Completed Results

• 4 other identifiers: RG1121550NCI-2021-04181STUDY00010137P30CA015704
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Colon Carcinoma; Malignant Solid Neoplasm; Ovarian Carcinoma; Pancreatic Carcinoma; Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

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.

Other: Electronic Health Record Review; Other: Questionnaire Administration; Behavioral: Behavioral Intervention

Interventions

Electronic Health Record Review OTHER

Medical data collected

Screening (medical records, coaching)

Questionnaire Administration OTHER

Complete questionnaires

Screening (medical records, coaching)

Behavioral Intervention BEHAVIORAL

Receive coaching

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Screening (medical records, coaching)

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Olympic Medical Cancer Center

Sequim, Washington, 98382, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Marianne Dubard-Gault
• Organization: University of Washington

mdg2019@uw.edu

206-606-6990

Study Officials

• Marianne Dubard-Gault

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 26, 2021
• Study Start: August 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 9, 2023
• Results First Posted: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)