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NCT Number: NCT02823652

Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer

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.

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Key information

Conditions

Advanced Malignant Neoplasm Locally Advanced Malignant Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

standard genetic education

Other

Undergo usual care

Other names: counseling, Counseling Intervention

Genetic Counseling

Other

Complete remote counseling

Genetic Testing

Other

Undergo germline testing

Other names: genetic analysis, Genetic Examination, Genetic Test

Internet-Based Intervention

Other

Complete on-line genetic education

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

  2. Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

  3. Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

  4. Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education

    Time frame: Assessed at baseline and up to 14 days post-baseline

    There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

  5. Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)

    Time frame: Assessed at baseline at Step 2

    Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".

  6. Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)

    Time frame: Assessed at baseline at Step 2

    Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".

Secondary outcomes

  1. Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

  2. Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

  3. Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

  4. Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex

    Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)

    There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

Other outcomes

  1. Factors Associated With Uptake of Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)

    Time frame: Assessed at baseline in Step 2

    The associations between patient characteristics and whether a patient receives genetic counseling will be evaluated.

  2. Cognitive and Affective Responses to Confirmatory Germline Testing (Step 2)

    Time frame: 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

    Cognitive and affective responses to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling will be evaluated.

  3. Satisfaction and Regret/Disappointment Related to Tumor Genetic Test Results

    Time frame: Assessed within 3 days of tumor test results received

    Satisfaction and regret/disappointment related to tumor genetic test results will be evaluated.

  4. How to Better Deliver Tumor Genetic Test Results and Germline Information in the Future

    Time frame: Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results received

    How to better deliver tumor genetic test results and germline information in the future will be evaluated.

  5. Behavioral Responses to Confirmatory Germline Testing

    Time frame: 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

    Behavioral responses (communication to others) to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling will be evaluated.

  6. Satisfaction and Regret/Disappointment Related to Genetic Counseling Service or Germline Genetic Test Results

    Time frame: 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

    Satisfaction and regret/disappointment related to genetic counseling service or germline genetic test results will be evaluated

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2016
Registry last updated
Feb 28, 2024

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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