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

NCT02823652 | Completed Results

• 2 other identifiers: EAQ152NCI-2015-02253
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Neoplasm; Locally Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (6)

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

  Assessed at baseline and up to 14 days post-baseline

• Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (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".

  Assessed at baseline at Step 2

• Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (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".

  Assessed at baseline at Step 2

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Other Outcomes (6)

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

  Assessed at baseline in Step 2

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

  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 Tumor Genetic Test Results

  Assessed within 3 days of tumor test results received

Study Arms (3)

Arm A (Step 1: internet-based intervention)

EXPERIMENTAL

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

Other: Internet-Based Intervention; Other: Survey Administration

Arm B (Step 1: usual care control)

ACTIVE COMPARATOR

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: standard genetic education; Other: Survey Administration

Step 2 - genetic counseling

EXPERIMENTAL

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

Other: Genetic Counseling; Other: Genetic Testing; Other: Survey Administration

Interventions

standard genetic education OTHER

Undergo usual care

Also known as: counseling, Counseling Intervention

Arm B (Step 1: usual care control)

Genetic Counseling OTHER

Complete remote counseling

Step 2 - genetic counseling

Genetic Testing OTHER

Undergo germline testing

Also known as: genetic analysis, Genetic Examination, Genetic Test

Step 2 - genetic counseling

Internet-Based Intervention OTHER

Complete on-line genetic education

Arm A (Step 1: internet-based intervention)

Survey Administration OTHER

Ancillary studies

Arm A (Step 1: internet-based intervention); Arm B (Step 1: usual care control); Step 2 - genetic counseling

Eligibility Criteria

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

You may qualify if:

• (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

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• 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.

  PMID: 34890045 DERIVED

MeSH Terms

Interventions

Counseling; Genetic Counseling; Genetic Testing

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Genetic Services; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG-ACRIN Statistical Office

eatrials@jimmy.harvard.edu

617-632-3012

Study Officials

• Angela Bradbury

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 6, 2016
• Study Start: October 25, 2016
• Primary Completion: December 26, 2019
• Study Completion: December 26, 2019
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2023-12

Locations

US (1)