Genetic Information and Family Testing Platform to Facilitate Genetic Testing for Cancer Patients' Families, GIFT Study

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT05552664
Trial Phases:		Protocol IDs:	UMCC 2022.066 (primary) NCI-2023-00010 HUM00224851
Eligibility:	18 Years and older, Male and Female	Study Type:	Prevention
Study Sponsor:	University of Michigan Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT05552664

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.