Inherited Cancer SyndromeIMPACTNCT04763915
Improving Care After Inherited Cancer Testing
A study testing Correlative Studies (Survey), Correlative Studies (Interview) and GeneSHARE in people with Inherited Cancer Syndrome and Prostate Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inherited Cancer Syndrome, Prostate Cancer, Colorectal Cancer
- What is being tested?
- Correlative Studies (Survey), Correlative Studies (Interview) and GeneSHARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
About this study
Official title: Improving Care After Inherited Cancer Testing (IMPACT) Study
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.
Read the detailed description
Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:
- Evaluate factors associated with access to genetic risk assessment, counseling, and testing services.
- Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results among individuals with a P/LP variant in an inherited cancer gene.
- Conduct a pilot study to assess the effectiveness of an intervention on improving FC of family cancer history among individuals with a VUS in an inherited cancer gene.
- Create and pilot an adaptive intervention to tailor resources to promote CRM and FC.
- Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.
- Conditions
- Inherited Cancer Syndrome, Prostate Cancer, Colorectal Cancer, Endometrial Cancer, Breast Cancer
- Being tested
- Correlative Studies (Survey), Correlative Studies (Interview), GeneSHARE, LivingLabReport, Standard-of-care & Adaptive Intervention
- Keywords
- Inherited Cancer Gene, Pathogenic/Likely Pathogenic Variant, Variant of Uncertain Significance, Cancer Risk Management, Family Sharing
- Medical subject headings
- Neoplastic Syndromes, Hereditary, Prostatic Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlative Studies (Survey)Other
Administer surveys
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
GeneSHAREBehavioural
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
LivingLabReportBehavioural
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.
Standard-of-care & Adaptive InterventionBehavioural
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.
Access to Education MaterialsOther
Receive access to VUS educational materials
| Study group | Role | What they receive |
|---|---|---|
| GeneSHARE | Experimental | Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results. Receives: 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. Receives: Other: Correlative Studies (Survey); Other: Correlative Studies (Interview); Behavioral: LivingLabReport |
| Standard-of-care | Active comparator | Receive standard-of-care from their treating healthcare provider. Receives: 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. Receives: Other: Correlative Studies (Survey); Other: Access to Education Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start5 Aug 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inherited Cancer SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of South Florida
- Responsible party
- Principal investigator, Tuya Pal, Vanderbilt-Ingram Cancer Center
- Investigators
- Tuya Pal, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763915
- Sponsor's protocol ID
- VICC SUPP 2112
- Other IDs
- U01CA254832
- Acronym
- IMPACT
- Status last verified
- Sep 2025
- First submitted
- 15 Feb 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34645413
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care After Inherited Cancer Testing (IMPACT) Study
- ClinicalTrials.gov ID
- NCT04763915
- Acronym / sponsor ID
- IMPACT / VICC SUPP 2112
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of South Florida
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:
- Evaluate factors associated with access to genetic risk assessment, counseling, and testing services.
- Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results among individuals with a P/LP variant in an inherited cancer gene.
- Conduct a pilot study to assess the effectiveness of an intervention on improving FC of family cancer history among individuals with a VUS in an inherited cancer gene.
- Create and pilot an adaptive intervention to tailor resources to promote CRM and FC.
- Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GeneSHARE | Experimental | Other: Correlative Studies (Survey), Other: Correlative Studies (Interview), Behavioral: GeneSHAREAccess to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results. |
| LivingLabReport | Experimental | Other: Correlative Studies (Survey), Other: Correlative Studies (Interview), Behavioral: LivingLabReportAccess 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. |
| Standard-of-care | Active comparator | Other: Correlative Studies (Survey), Other: Correlative Studies (Interview), Behavioral: Standard-of-care & Adaptive InterventionReceive standard-of-care from their treating healthcare provider. |
| Variants of Uncertain Significance (VUS) Pilot Study | Experimental | Other: Correlative Studies (Survey), Other: Access to Education MaterialsParticipants are provided access to VUS educational resources including video and written education and assistance for speaking with family members. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlative Studies (Survey)Administer surveys | Other | GeneSHARE, LivingLabReport, Standard-of-care, Variants of Uncertain Significance (VUS) Pilot Study |
| Correlative Studies (Interview)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 | Other | GeneSHARE, LivingLabReport, Standard-of-care |
| GeneSHAREAccess to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results. | Behavioural | GeneSHARE |
| LivingLabReportAccess 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. | Behavioural | LivingLabReport |
| Standard-of-care & Adaptive InterventionReceive 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. | Behavioural | Standard-of-care |
| Access to Education MaterialsReceive access to VUS educational materials | Other | Variants of Uncertain Significance (VUS) Pilot Study |
Primary outcome
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)
Time frame: 12 months
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
Change in CRM
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 34645413Cragun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuya Pal, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correlative Studies (Survey), Correlative Studies (Interview) and GeneSHARE in people with Inherited Cancer Syndrome and Prostate Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.