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Trial record 1 of 1 for:    eaq152
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Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer

This study is currently recruiting participants.
Verified October 2017 by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02823652
First Posted: July 6, 2016
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
  Purpose
This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.

Condition Intervention
Advanced Malignant Neoplasm Locally Advanced Malignant Neoplasm Other: Counseling Other: Genetic Counseling Other: Genetic Testing Other: Internet-Based Intervention Other: Survey Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Test Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants With Potential Germline Mutations Identified on Tumor Profiling

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Primary Outcome Measures:
  • Difference in change scores: State Inventory of the State-Trait Anxiety Index [ Time Frame: Assessed at baseline and up to 14 days post-baseline ]
    Will measure anxiety before and after genetic education or usual care

  • Difference in change scores: Impact of Events Scale (IES) [ Time Frame: Assessed at baseline and up to 14 days post-baseline ]
    Will measure cancer-specific distress before and after genetic education or usual care

  • Difference in change scores: Cancer Genetic Knowledge Scale [ Time Frame: Assessed at baseline and up to 14 days post-baseline ]
    Will measure knowledge about genetic diseases and inherited diseases before and after genetic education or usual care

  • Difference in change scores: PROMIS emotional distress: anxiety [ Time Frame: Assessed at baseline and up to 14 days post-baseline ]
    Will measure anxiety before and after genetic education or usual care

  • Differences in change scores: PROMIS emotional distress: depression [ Time Frame: Assessed at baseline and up to 14 days post-baseline ]
    Will measure depression before and after genetic education or usual care

  • Proportion of substudy participants who complete both remote genetic counseling and germline testing [ Time Frame: Assessed at substudy eligibility and within 3 days after germline testing or decline of germline testing ]
    Will test whether the uptake rate (proportion of participants who complete both genetic counseling and germline testing) exceeds the null hypothesized rate of 50%


Secondary Outcome Measures:
  • Factors associated with uptake of clinical germline testing [ Time Frame: Assessed within 3 days of receiving germline testing results ]
    Knowledge about germline testing will be assessed before and after counseling

  • Factors associated with uptake of remote genetic counseling [ Time Frame: Assessed within 3 days of receiving genetic counseling ]
    Knowledge about the impact of receiving information about potential clinically significant incidental germline mutations will be evaluated.


Estimated Enrollment: 400
Study Start Date: September 2016
Estimated Study Completion Date: September 2026
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (internet-based intervention)
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
Other: Internet-Based Intervention
Complete on-line genetic education
Other: Survey Administration
Ancillary studies
Active Comparator: Group II (usual care control)
Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.
Other: Counseling
Undergo usual care
Other Name: Counseling Intervention
Other: Survey Administration
Ancillary studies
Experimental: Group III (genetic counseling)
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
Other: Genetic Counseling
Complete remote counseling
Other: Genetic Testing
Undergo germline testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test
Other: Survey Administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of web-based pre-test genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations). (Step 1)

II. To evaluate the efficacy of web-based pre-test genetic education (i.e. before receipt of tumor profile results) to decrease distress (anxiety, depression and cancer specific worry) compared to usual care services in patients undergoing tumor profiling for advanced cancer. (Step 1)

III. To evaluate the uptake of remote genetic counseling (Step 2)

IV. To evaluate the uptake of germline testing among advanced cancer patients with a potential clinically significant incidental germline mutation identified through tumor profiling in the Molecular Analysis for Therapy Choice (MATCH) trial. (Step 2)

SECONDARY OBJECTIVES:

I. To evaluate potential moderators suggested by the self-regulation theory of health behavior (SRTHB) (e.g. test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in knowledge of genetic disease and test benefits and limitations. (Step 1)

II. To evaluate potential moderators suggested by the SRTHB (e.g test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in distress in patients undergoing tumor profiling for advanced cancer. (Step 1)

III. To evaluate factors associated with uptake of genetic counseling and germline testing. (Step 2)

IV. To evaluate cognitive, affective and behavioral (communication to relatives) responses to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling. (Step 2)

OUTLINE:

STEP I (PRIMARY INTERVENTION STUDY): Participants are randomized to 1 of 2 arms.

ARM A: Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.

ARM B: Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.

STEP II (SECONDARY GENETIC COUNSELING SUBSTUDY):

Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.

After completion of study treatment, patients are followed up periodically.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):
  • Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
  • Patients must speak English and have an adequate ability to view a website (primary intervention study)
  • (STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
  • Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
  • Patients must be able to speak English and hear by phone
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823652


Locations
United States, Pennsylvania
ECOG-ACRIN Cancer Research Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Angela R. Bradbury    215-615-3341    angela.bradbury@uphs.upenn.edu   
Principal Investigator: Angela R. Bradbury         
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Angela Bradbury ECOG-ACRIN Cancer Research Group
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT02823652     History of Changes
Other Study ID Numbers: EAQ152
NCI-2015-02253 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAQ152 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EAQ152 ( Other Identifier: CTEP )
First Submitted: June 21, 2016
First Posted: July 6, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neoplasms