Improving Care After Inherited Cancer Testing

NCT04763915 | Active Not Recruiting DMC

• 2 other identifiers: VICC SUPP 2112U01CA254832
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

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

Inherited Cancer Syndrome; Prostate Cancer; Colorectal Cancer; Endometrial Cancer; Breast Cancer

Keywords

Inherited Cancer Gene; Pathogenic/Likely Pathogenic Variant; Variant of Uncertain Significance; Cancer Risk Management; Family Sharing

Outcome Measures

Primary Outcomes (2)

• Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)

  Having at least one additional at-risk adult, living relative with whom the participant has shared their test result, information about testing, or family history of cancer for the first time or has subsequently followed up with a relative

  12 months

• Change in CRM

  Ongoing guideline-adherent CRM or a change towards guideline-adherent CRM per National Comprehensive Cancer Network (NCCN) CRM guidelines based on genetic test results as measured by survey data and verified through medical records where possible and/or appropriate.

  12 months

Study Arms (4)

GeneSHARE

EXPERIMENTAL

Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.

Other: Correlative Studies (Survey); Other: Correlative Studies (Interview); Behavioral: GeneSHARE

LivingLabReport

EXPERIMENTAL

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.

Other: Correlative Studies (Survey); Other: Correlative Studies (Interview); Behavioral: LivingLabReport

Standard-of-care

ACTIVE COMPARATOR

Receive standard-of-care from their treating healthcare provider.

Other: Correlative Studies (Survey); Other: Correlative Studies (Interview); Behavioral: Standard-of-care & Adaptive Intervention

Variants of Uncertain Significance (VUS) Pilot Study

EXPERIMENTAL

Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.

Other: Correlative Studies (Survey); Other: Access to Education Materials

Interventions

Correlative Studies (Survey) OTHER

Administer surveys

GeneSHARE; LivingLabReport; Standard-of-care; Variants of Uncertain Significance (VUS) Pilot Study

Correlative Studies (Interview) OTHER

In-depth interviews among a subset of participants after the 12-month follow-up survey to either: 1) determine additional resources and tailored message that would be helpful; or 2) assess the adaptive intervention

GeneSHARE; LivingLabReport; Standard-of-care

GeneSHARE BEHAVIORAL

Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.

GeneSHARE

LivingLabReport BEHAVIORAL

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.

LivingLabReport

Standard-of-care & Adaptive Intervention BEHAVIORAL

Receive standard-of-care from their treating healthcare provider. A subset of individuals will also be asked to test and pilot the adaptive intervention, which will consist of tailored resources to promote CRM and FC, after the 12-month follow-up survey.

Standard-of-care

Access to Education Materials OTHER

Receive access to VUS educational materials

Variants of Uncertain Significance (VUS) Pilot Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 gene

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of South Florida: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Cragun 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 DERIVED

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary; Prostatic Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Breast Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services Administration

Study Officials

• Tuya Pal, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Cancer Health Disparities

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: August 5, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)