Clinical trial · Interventional
Improving Care After Inherited Cancer Testing
Improving Care After Inherited Cancer Testing (IMPACT) Study
NCT04763915CI-TRIAL-00095433IMPACTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Inherited Cancer Syndrome | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Access to Education Materials | Other | — | UNRESOLVED |
| Correlative Studies (Interview) | Other | — | UNRESOLVED |
| Correlative Studies (Survey) | Other | — | UNRESOLVED |
| GeneSHARE | Behavioral | — | UNRESOLVED |
| LivingLabReport | Behavioral | — | UNRESOLVED |
| Standard-of-care & Adaptive Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- GeneSHARE
- description
- Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
- interventionNames
- Other: Correlative Studies (Survey)
- Other: Correlative Studies (Interview)
- Behavioral: GeneSHARE
- type
- EXPERIMENTAL
- label
- LivingLabReport
- description
- Access to LivingLabReport, a website containing multiple resources including a summary of the patient's genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services.
- interventionNames
- Other: Correlative Studies (Survey)
- Other: Correlative Studies (Interview)
- Behavioral: LivingLabReport
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Randomized Controlled Trial Eligibility: All trial participants will be autonomous adults who are capable of participating in the study
Inclusion Criteria:
* English-speaking men and women aged 18 years or older
* Not adopted (i.e., have information about their biological relatives)
* Have access to internet and a computer, tablet, or smartphone
* Documented pathogenic/likely pathogenic variant in an inherited cancer gene that has CRM guidelines listed in the National Comprehensive Cancer Network (NCCN) Genetic/Familial Panel focused on Breast, Ovarian, and Pancreatic or Colorectal cancers
* Must meet at least one of the following criteria:
* Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either:
* has not been told about the genetic test result by the participant
* has not had their own genetic testing
* Intervention B (LivingLabReport) criteria: Are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current NCCN CRM guidelines or if currently adherent, require ongoing cancer screening
VUS Pilot Study Eligibility: All VUS pilot study participants will be autonomous adults who are capable of participating in the study. Eligibility criteria include:
* English-speaking men and women aged 18 years or older
* Not adopted (i.e., have information about their biological relatives)
* Have access to internet and a computer, tablet, or smartphone
* Documented VUS in an inherited cancer geneReferences
Publications (1)
- DERIVEDCragun D, Beckstead J, Farmer M, Hooker G, Dean M, Matloff E, Reid S, Tezak A, Weidner A, Whisenant JG, Pal T. IMProving care After inherited Cancer Testing (IMPACT) study: protocol of a randomized trial evaluating the efficacy of two interventions designed to improve cancer risk management and family communication of genetic test results. BMC Cancer. 2021 Oct 13;21(1):1099. doi: 10.1186/s12885-021-08822-4. PMID 34645413