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OpenTrials
Completed

NCT Number: NCT04902144

Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

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.

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Key information

Conditions

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

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olympic Medical Cancer Center

Sequim, Washington, 98382, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Electronic Health Record Review

Other

Medical data collected

Questionnaire Administration

Other

Complete questionnaires

behavioral intervention

Behavioral

Receive coaching

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Primary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 26, 2021
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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