N/A
N=601
Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
Advanced Malignant Neoplasm · Locally Advanced Malignant Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT02823652 ↗Enrolled (actual)
601
Serious AEs
—
Results posted
Feb 2024
Primary outcome: Primary: Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education — 1.43; -0.80 score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- standard genetic education (Other); Genetic Counseling (Other); Genetic Testing (Other); Internet-Based Intervention (Other); Survey Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education |
1.43; -0.80 | <.0001 sig |
| PRIMARY Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education |
0.23; -0.30 | 0.035 sig |
| PRIMARY Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education |
-0.32; -0.55 | 0.312 |
| PRIMARY Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education |
-1.79; -0.19 | 0.11 |
| PRIMARY Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) |
0.43; 0.5; 0.71 | — |
| PRIMARY Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2) |
0.43; 0.25; 0.57 | — |
| SECONDARY Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex |
1.4; -0.5; 1.5; -1.1 | — |
| SECONDARY Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex |
0.2; 0; 0.2; -0.6 | — |
| SECONDARY Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex |
-0.3; -0.4; -0.3; -0.6 | — |
| SECONDARY Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex |
-0.9; -1.5; -2.4; 0.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02823652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.