The Genetic Information and Family Testing (GIFT) Study

NCT05552664 | Completed

• 4 other identifiers: UMCC 2022.066HUM00224851U01CA254822HUM00221150
• Study Type: interventional
• Target: 3,002
• Locations: 1 country
• Sites: 4

Brief 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 subsequently engage their clinicians in informed decision-making about cancer prevention and early detection.

Conditions

Cancer

Keywords

Genetic Testing; Family testing

Outcome Measures

Primary Outcomes (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.

  6 months after the final relative enrolls

Secondary Outcomes (3)

• 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.

  91 days after the final patient enrolls

• 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.

  After the 6 month follow up survey

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

  After the 6 month follow up survey

Study Arms (4)

Arm 1

OTHER

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Genetic: GIFT

Arm 2

OTHER

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Genetic: GIFT

Arm 3

OTHER

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Genetic: GIFT

Arm 4

OTHER

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Genetic: GIFT

Interventions

GIFT GENETIC

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.

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• A positive test result (pathogenic variant; PV)
• 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.

You may not qualify if:

• \) Age\<18
• 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
• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Southern California

Los Angeles, California, 90007, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48108, United States

Location

Related Publications (1)

• 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.

  PMID: 40016666 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Steven Katz, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be concealed from study participants; enrolled patients and relatives will not be aware that their family has been randomized into one of four trial arms and provided a different intervention experience than the other study participants. Concealment is necessary for this study so that the trial can observe differences across the trial arms without a) negatively impacting study enrollment and biasing the study, and b) causing unnecessary negative emotional reactions in study participants.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is a 2x2 factorial prospective RCT

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 24, 2022
• Primary Completion: July 10, 2025
• Study Completion: August 10, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (4)