Video Education with Result Dependent Disclosure to Improve Genetic Testing Uptake and Patient Outcomes, VERDI Study
This clinical trial investigates the impact of video education and result dependent disclosure on genetic testing uptake rates and patient outcomes in patients with a history of solid tumors. An educational video on cancer genetics may help patients learn more about the inherited causes of cancer and increase genetic testing update in patients with a history of solid tumors.
Inclusion Criteria
- PATIENT INTERVIEWS: Age >= 18 years
- PATIENT INTERVIEWS: Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
- PATIENT INTERVIEWS: Ability to understand spoken or written English or Spanish in a healthcare context
- PATIENT INTERVIEWS: Ability to understand and the willingness to sign a written informed consent document
- PATIENT INTERVIEWS: Black or Latinx (qualitative assessment study only)
- RANDOMIZED CONTROLLED TRIAL: Age ≥ 18 years
- RANDOMIZED CONTROLLED TRIAL: Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
- RANDOMIZED CONTROLLED TRIAL: Ability to understand spoken or written English or Spanish in a healthcare context
- RANDOMIZED CONTROLLED TRIAL: Ability to understand and the willingness to sign a written informed consent document
- GENETIC COUNSELOR INTERVIEWS: Age >= 18 years
- GENETIC COUNSELOR INTERVIEWS: Licensed genetic counselor (GC) practitioner
- GENETIC COUNSELOR INTERVIEWS: Experience working with patients diagnosed with cancer
- GENETIC COUNSELOR INTERVIEWS: Ability to understand written and spoken English
- GENETIC COUNSELOR INTERVIEWS: Ability to understand the process and goals of the study
- GENETIC COUNSELOR INTERVIEWS: Willingness to participate in the study
- GENETIC COUNSELOR SURVEY: Age >= 18 years
- GENETIC COUNSELOR SURVEY: Sees an average of at least three patients per week for cancer genetic counseling
- GENETIC COUNSELOR SURVEY: Ability to understand written and spoken English
- GENETIC COUNSELOR SURVEY: Ability to understand the process and goals of the study
- GENETIC COUNSELOR SURVEY: Willingness to participate in the study
Exclusion Criteria
- PATIENT INTERVIEWS: Prior germline cancer panel genetic testing
- PATIENT INTERVIEWS: Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- PATIENT INTERVIEWS: Currently pregnant
- PATIENT INTERVIEWS: Currently incarcerated
- RANDOMIZED CONTROLLED TRIAL: Prior germline cancer panel genetic testing
- RANDOMIZED CONTROLLED TRIAL: Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- RANDOMIZED CONTROLLED TRIAL: Currently pregnant, per verbal participant report
- RANDOMIZED CONTROLLED TRIAL: Currently incarcerated
Additional locations may be listed on ClinicalTrials.gov for NCT05225428.
Locations matching your search criteria
United States
Massachusetts
Boston
Brighton
Foxborough
Methuen
Milford
South Weymouth
New Hampshire
Londonderry
New Jersey
New Brunswick
PRIMARY OBJECTIVES:
I. To develop a refined, streamlined, tumor agnostic, pretest video education (VE) and post-test result delivery model that results in increased genetic testing uptake and improved patient-reported outcomes for diverse patients. (Patient Interviews)
II. To evaluate the impact of pretest VE in a diverse population on intervention completion, genetic testing uptake, genetic testing satisfaction, genetic testing psychosocial impacts, genetic testing knowledge, and genetic testing family communication as reported by participants. (Randomized Controlled Trial)
SECONDARY OBJECTIVE:
I. Assess the impact of pretest VE in a diverse population on Genetic Counselors and costs to inform practice. (Randomized Controlled Trial)
OUTLINE:
PATIENT INTERVIEWS: Participants view an educational video about cancer genetics over 8-10 minutes and then participate in an interview.
GENETIC COUNSELOR INTERVIEWS: Participants participate in an interview.
GENETIC COUNSELOR SURVEY: Participants complete a survey.
RANDOMIZED CONTROLLED TRIAL: Participants are randomized to 1 of 2 arms.
ARM I: Participants view an educational video about cancer genetics. Participants may then undergo genetic testing. Participants with positive genetic testing results receive a phone call informing them of results. Participants with a negative genetic testing result or variant of uncertain significance receive a result letter informing them of results.
ARM II: Participants undergo genetic counseling per standard of care. Participants may then undergo genetic testing. Participants receive a phone call from genetic counselor informing them of genetic testing results.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHuma Q Rana
- Primary ID21-508
- Secondary IDsNCI-2022-04761
- ClinicalTrials.gov IDNCT05225428