Clinical trial NCT02823652: Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
Official title: COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Disclosure 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Malignant Neoplasm
Locally Advanced Malignant Neoplasm
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-06
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the efficacy of web-based pre-disclosure 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-disclosure 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 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

Primary outcomes:
measure: Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
measure: Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
measure: Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
measure: Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education
timeFrame: Assessed at baseline and up to 14 days post-baseline
measure: Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)
timeFrame: Assessed at baseline at Step 2
measure: Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)
timeFrame: Assessed at baseline at Step 2
Secondary outcomes:
measure: Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
measure: Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
measure: Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
measure: Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex
timeFrame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Other outcomes:
measure: Factors Associated With Uptake of Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)
timeFrame: Assessed at baseline in Step 2
measure: Cognitive and Affective Responses to Confirmatory Germline Testing (Step 2)
timeFrame: Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2
measure: Satisfaction and Regret/Disappointment Related to Tumor Genetic Test Results
timeFrame: Assessed within 3 days of tumor test results received
measure: How to Better Deliver Tumor Genetic Test Results and Germline Information in the Future
timeFrame: Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results received
measure: Behavioral Responses to Confirmatory Germline Testing
timeFrame: Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2
measure: Satisfaction and Regret/Disappointment Related to Genetic Counseling Service or Germline Genetic Test Results
timeFrame: Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2
Locations:
city: Philadelphia
country: United States
facility: ECOG-ACRIN Cancer Research Group
state: Pennsylvania
Study officials:
affiliation: ECOG-ACRIN Cancer Research Group
name: Angela Bradbury
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradbury AR, Lee JW, Gaieski JB, Li S, Gareen IF, Flaherty KT, Herman BA, Domchek SM, DeMichele AM, Maxwell KN, Onitilo AA, Virani S, Park S, Faller BA, Grant SC, Ramaekers RC, Behrens RJ, Nambudiri GS, Carlos RC, Wagner LI. A randomized study of genetic education versus usual care in tumor profiling for advanced cancer in the ECOG-ACRIN Cancer Research Group (EAQ152). Cancer. 2022 Apr 1;128(7):1381-1391. doi: 10.1002/cncr.34063. Epub 2021 Dec 10.