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CancerGIFTNCT05552664

The Genetic Information and Family Testing (GIFT) Study

A study testing GIFT in people with Cancer, run by University of Michigan Rogel Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Genetic Information and Family Testing (GIFT) Study is designed to support the capacity, opportunity, and motivation of cancer patients to engage their relatives about inherited cancer susceptibility and provide support and services to those relatives to initiate GRE (including genetic testing) and prepare them to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
GIFT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,002 participants
Where
4 sitesUnited States
Study dates
24 Oct 2022to 10 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosed with any cancer at any stage in 2018-2019 and reported to the Georgia or California SEER registries
  • Been found to carry a pathogenic variant (PV) in one of 27 cancer susceptibility genes (see Table 4) according to the Georgia California Genetic Testing Linkage Initiative dataset
  • aged 18 or older
  • alive at the time of selection as determined through linkage with Georgia and California vital statistics data.
  • Additional eligibility criteria for Patient Trial Invitation will be evaluated from patient response to the PICS survey and will include patient report of:
  • Receipt of genetic testing for cancer risk
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  • A positive test result (pathogenic variant; PV)
  • Inclusion criteria for Relative Trial Invitation are assessed via patient report:
  • first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relative of a patient enrolled in the study;
  • aged 18 or older;
  • alive at the time of study invitation;
  • relative lives in the United States or Canada (countries in which Color genetic testing is available, most people speak either English or Spanish, and test kit shipping costs are not exorbitant)
  • Additional eligibility criteria for Relative Trial Enrollment will be evaluated from relative response to the relative eligibility screening survey (see Appendix C) and will include:
  • confirmation from the relative that they have not received clinical genetic testing ordered by a doctor or genetic counselor within the past five years (proxy for having already been tested for the PV carried by the patient who invited them into the study);
  • confirmation of age 18 or older;
  • confirmation of first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relation to the patient.
  • confirmation of residence in United States or Canada

Who cannot join

  • 1) Age<18
  • Additional exclusion criteria for Patient Trial Invitation:
  • Patients who do not report receipt of genetic testing
  • Patients who do not report a positive genetic test result (PV)
  • Age<18
  • Relative does not live in the United States or Canada
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  • Additional exclusion criteria for Relative Trial Enrollment include relative report of:
  • Age<18;
  • Receipt of genetic testing ordered by a doctor or genetic counselor within the past five years;
  • Relationship to proband (inviting) patient other than first- or second-degree relative
  • Residence in a country other than United States or Canada

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48108

  • Emory University

    Atlanta, Georgia, 30322

  • University of Southern California

    Los Angeles, California, 90007

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

The Genetic Information and Family Testing (GIFT) Study is designed to support the capacity, opportunity, and motivation of cancer patients to engage their relatives about inherited cancer susceptibility and provide support and services to those relatives to initiate GRE (including genetic testing) and prepare them to subsequently engage their clinicians in informed decision-making about cancer prevention and early detection.

Read the detailed description

GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing. Two design features of the intervention will be randomized and evaluated to determine the best approach for future scalability.

Those eligible will be offered enrollment into the Michigan-hosted intervention trial, and those who enroll will be randomized into 1 of 4 study arms. Patients can invite their relatives to enroll and receive genetic testing via Color. Families randomized to the arms with human Navigator support will also have access to a Family Health Navigator at Stanford University. Enrolled patients and relatives will be surveyed six months post-enrollment to collect additional information regarding their interactions with the GIFT platform and their experiences with genetic risk evaluation.

Study phase and approximate sample size is summarized below:

  • Initial patient sample selected- 5250 patients
  • Respondents to PICS survey- 3150 patients
  • Pool of patients eligible for GIFT study invitation- 2930 patients
  • Patient GIFT study participants- 880 patients
  • Relatives invited to the GIFT study- 3520 relatives
  • Relative GIFT study participants- 1584 relatives

Study phase and approximate sample size summarizes have been updated below and IRB approved 29SEP2025:

  • Initial patient sample selected- 4300 patients
  • Respondents to PICS survey- 2358 patients
  • Pool of patients eligible for GIFT study invitation- 2030 patients
  • Patient GIFT study participants- 412 patients
  • Relatives invited to the GIFT study- 1236 relatives
  • Relative GIFT study participants- 371 relatives
Conditions
Cancer
Being tested
GIFT
Keywords
Genetic Testing, Family testing
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIFTGenetic

    GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing.

Study groups in NCT05552664
Study groupRoleWhat they receive
Arm 1OtherArm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
Receives: Genetic: GIFT
Arm 2OtherArm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
Receives: Genetic: GIFT
Arm 3OtherArm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
Receives: Genetic: GIFT
Arm 4OtherArm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
Receives: Genetic: GIFT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing.

    The proportion of each enrolled patient's 1st and 2nd degree relatives who receive Color genetic testing through the GIFT platform.

    For each enrolled patient, this will be calculated as the number of enrolled relatives who obtain a genetic test result from Color (complete the genetic testing process) via the GIFT Study divided by the number of relatives reported on the baseline PICS survey. The endpoint of interest is the presence (as opposed to the absence) of a test result (e.g., positive, uncertain, negative) on the Color Quarterly Report.

    Assessed six months after the final relative enrolls in the study.

    Measured: 6 months after the final relative enrolls

Secondary outcomes (3)

  1. To determine the independent effects of the two virtual platform design features on the proportion of relatives invited by each patient to enroll in the study.

    The proportion of each enrolled patient's relatives who are invited to join the study. For each enrolled patient:

    Number of invited relatives / Number of relatives reported on baseline PICS survey

    Assessed 91 days after the final patient enrolls in the study.

    Measured: 91 days after the final patient enrolls

  2. To determine the independent effects of the two virtual platform design features on the cancer patients' assessment of communication with their relatives about hereditary cancer and genetic risk evaluation.

    A 20-item scale with responses on a 5-point Likert from "not at all true" to "very true." Items assess patients' capacity, opportunity, and motivation to communicate with family members about their genetic test results. The outcome is continuous and we will measure the change in mean score from baseline to follow-up survey. A greater difference between timepoints will indicate greater improvement in the patient's assessment of their communication with relatives.

    Assessed at two time points: baseline PICS survey and Patient Six-Month Follow-up Survey.

    Measured: After the 6 month follow up survey

  3. To determine the independent effects of the two virtual platform design features on relatives' receipt of a formal cancer genetic counseling session in practice.

    Single question on a binary yes/no scale. Yes will indicate receipt of formal GRE.

    Assessed in the Relative Six-Month Follow-Up Survey

    Measured: After the 6 month follow up survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start24 Oct 2022
  3. Primary completion10 Jul 2025
  4. Study completion10 Aug 2025

Resources

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
Factorial
Model description
The trial is a 2x2 factorial prospective RCT
Masking
Single blind
Who is masked
Participant
Enrolment
3,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552664
Sponsor's protocol ID
UMCC 2022.066
Other IDs
HUM00224851, U01CA254822, HUM00221150
Acronym
GIFT
Status last verified
Jan 2026
First submitted
20 Sep 2022
Last updated
26 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Katz SJ, Hofer TP, Abrahamse P, Courser RR, Hodan R, Tocco RS, Rios-Ventura S, Ward KC, Hamilton AS, Frey MK, An LC, Kurian AW. Results From the Genetic Information and Family Testing Study: A Cluster-Randomized Trial. J Clin Oncol. 2026 May;44(13):1216-1224. doi: 10.1200/JCO-25-02196. Epub 2026 Mar 24.

    PubMed 41875376

  • Katz SJ, Abrahamse P, Hofer TP, Courser RR, Hodan R, Tocco RS, Rios-Ventura S, Ward KC, Hamilton AS, Kurian AW, An LC. The Genetic Information and Family Testing (GIFT) study: trial design and protocol. BMC Cancer. 2025 Feb 27;25(1):366. doi: 10.1186/s12885-025-13744-6.

    PubMed 40016666

Questions about this trial

What is this clinical trial studying?

A study testing GIFT in people with Cancer, run by University of Michigan Rogel Cancer Center at 4 sites 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 17 inclusion and 11 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing. (time frame: 6 months after the final relative enrolls). 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 NCT05552664, which also lists 2 linked publications.

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 26 Jan 2026.

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