This clinical trial tests the Supporting UnderRepresented Minorities in Genomics-Based Cancer Trial Enrollment (SURGE) patient navigation intervention for those with cancers that have spread to other places in the body (advanced). Clinical trials inform treatment strategies for patients diagnosed with cancer, yet Black, Latinx, American Indian, Pacific Islander, older adults, and those with limited English proficiency (LEP) and low socioeconomic status (SES) who are disproportionately affected by this disease are underrepresented. The recruitment of these vulnerable patients into clinical trials has been difficult with low enrollment rates. The use of genomic testing is an important precursor to clinical trial enrollment, recommended by the National Comprehensive Cancer Network (NCCN), that allows for matching patients to specific clinical trials based on their molecular profile that can be used to guide treatment for many cancers. However, recent data points to under-use of genomic testing for patients of color, low SES, and patients who are not seen at National Cancer Institute (NCI) cancer centers. The current standard of care is providing information on clinical trials and genomic testing is part of routine patient care through the oncology provider. The addition of the SURGE program which involves screening questionnaires for clinical trial enrollment readiness, an informational video, and assignment of a patient navigator to assist underrepresented patients early in their diagnosis of advanced cancer may be effective in increasing cancer clinical trials awareness, readiness, and/or participation and genomic testing.
Additional locations may be listed on ClinicalTrials.gov for NCT05375643.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Nadine Jackson McCleary
Phone: 617-632-6729
Brighton
Dana-Farber Cancer Institute at Boston Medical Center - BrightonStatus: Active
Contact: Olga Kozyreva
Phone: 617-789-2903
Methuen
Dana Farber-Merrimack ValleyStatus: Active
Contact: Pedro M. Sanz-Altamira
PRIMARY OBJECTIVE:
I. Conduct an in-clinic pilot intervention implementing the video educational tool with or without patient navigation among 210 patients (at least 25% historically underrepresented patients [HUP]) newly diagnosed with advanced cancer to examine intervention and implementation outcomes.
II. Compare efficacy of video-based education with or without patient navigation improving genomic testing consent and clinical trial enrollment. (Intervention Outcome- Primary)
III. Determine feasibility and acceptability of the SURGE intervention (video-based education with/without patient navigation). (Implementation Outcomes)
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients complete a screening questionnaire ascertaining baseline awareness and interest in clinical trials the day following patient enrollment with additional follow-up messaging if no response is received. Patients offered clinical trial and PROFILE genomic testing information at their consultation visits with their oncology provider, per current clinical practices and routine patient care.
ARM B: Patients complete a screening questionnaire ascertaining baseline awareness and interest in clinical trials the day following patient enrollment with additional follow-up messaging if no response is received. Patients receive a link to an informational video about clinical trials and genomic testing via text messaging.
ARM C: Patients complete a screening questionnaire ascertaining baseline awareness and interest in clinical trials the day following patient enrollment with additional follow-up messaging if no response is received. Patients receive a link to an informational video about clinical trials and genomic testing via text messaging. All patients receive patient navigation via phone, video, or in-clinic visits providing support regarding PROFILE genomic testing, cancer clinical trials, and resource referrals to address social determinants of health (SDoH) needs 24-28 hours following enrollment to intervention and every month for six months.
After completion of study intervention, patients are followed for six months or until transfer of care outside of Dana Farber Cancer Institute (DFCI) Longwood/Chestnut Hill (CH), DFCI St. Elizabeth’s Medical Center (SEMC), DFCI Merrimack Valley, or death.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorNadine Jackson McCleary
