Genetic Information and Family Testing Platform to Facilitate Genetic Testing for Cancer Patients' Families, GIFT Study
18 Years and older, Male and Female
UMCC 2022.066 (primary)
NCI-2023-00010
HUM00224851
Summary
This clinical trial tests a genetic information and family testing (GIFT) platform for facilitating genetic testing for cancer patients' families. Some families are at a higher risk for cancer because of changes or mutations that can happen to certain genes. In these families, it is important for family members to consider genetic testing to help them understand if they do or do not have an increased genetic risk for cancer. Using the GIFT platform to facilitate genetic testing may help cancer patients' families learn more about their family cancer risk and ways to reduce that risk.
Objectives
PRIMARY OBJECTIVE:
I. To determine the independent effects of the two virtual platform design features on relatives’ receipt of genetic testing.
SECONDARY OBJECTIVES:
I. 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.
II. 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.
III. To determine the independent effects of the two virtual platform design features on relatives’ receipt of a formal cancer genetic counseling session in practice.
EXPLORATORY AIM:
I. To explore the effect of the two virtual platform design features on the primary and secondary relatives testing outcomes across patient socioeconomic status (SES) subgroups.
OUTLINE: Patients are randomized in to 1 of 4 arms.
ARM I: Patients access the GIFT platform to receive genetics and cancer risk education and manage relative communication while on study. Relatives access the GIFT platform to receive genetics and cancer risk education and optional genetic testing for no cost while on study. Patients and relatives complete surveys throughout the study.
ARM II: Patients access the GIFT platform to receive genetics and cancer risk education and manage relative communication while on study. Relatives access the GIFT platform to receive genetics and cancer risk education and optional genetic testing for a cost while on study. Patients and relatives complete surveys throughout the study.
ARM III: Patients access the GIFT platform to receive genetics and cancer risk education and manage relative communication while on study. Relatives access the GIFT platform to receive genetics and cancer risk education and optional genetic testing for no cost. Both patients and relatives also receive access to navigation services while on study. Patients and relatives complete surveys throughout the study.
ARM IV: Patients access the GIFT platform to receive genetics and cancer risk education and manage relative communication while on study. Relatives access the GIFT platform to receive genetics and cancer risk education and optional genetic testing for a cost while on study. Both patients and relatives also receive access to navigation services while on study. Patients and relatives complete surveys throughout the study.
Eligibility
- PATIENT INCEPTION COHORT SURVEY: Diagnosed with any cancer at any stage in 2018-2019 and reported to the Georgia or California Surveillance, Epidemiology, and End Results (SEER) registries
- PATIENT INCEPTION COHORT SURVEY: Been found to carry a pathogenic variant (PV) in one of 27 cancer susceptibility genes according to the Georgia California Genetic Testing Linkage Initiative dataset
- PATIENT INCEPTION COHORT SURVEY: Aged 18 or older
- PATIENT INCEPTION COHORT SURVEY: Alive at the time of selection as determined through linkage with Georgia and California vital statistics data (to be updated routinely; surveys will not be sent knowingly to deceased patients)
- PATIENT TRIAL INVITATION: Receipt of genetic testing for cancer risk
- PATIENT TRIAL INVITATION: A positive test result (pathogenic variant; PV)
- RELATIVE TRIAL INVITATION: 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 pilot study
- RELATIVE TRIAL INVITATION: Aged 18 or older
- RELATIVE TRIAL INVITATION: Alive at the time of study invitation
- RELATIVE TRIAL INVITATION: Relative lives in the United States, Canada, or Mexico (countries in which Color genetic testing is available, most people speak either English or Spanish, and test kit shipping costs are not exorbitant)
- RELATIVE TRIAL ENROLLMENT: 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)
- RELATIVE TRIAL ENROLLMENT: Confirmation of age 18 or older
- RELATIVE TRIAL ENROLLMENT: 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
- RELATIVE TRIAL ENROLLMENT: Confirmation of residence in United States, Canada, or Mexico
Treatment Sites in Georgia
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