This clinical trial studies the use of a new, web-based program called SmartManage in reducing symptom burden in sexual minority men living with both human immunodeficiency virus (HIV) and cancer that has not spread to other places in the body (non-metastatic). The limited research on sexual minority men with cancer suggest that many experience heightened symptom bother, greater decline in psychosocial adjustment, poorer sexual functioning, and overall poorer wellbeing relative to heterosexual men. Furthermore, sexual minority men with cancer experience significant concerns around minority status and stigmatization. SmartManage is a cognitive behavioral stress and self-management intervention that may address the unique needs of HIV+ gay and bisexual men living with non-metastatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04544917.
PRIMARY OBJECTIVE:
I. To adapt and refine a web-based delivered psychosocial intervention to address the unique needs of HIV+ cancer survivors.
OUTLINE:
STAGE I: Patients complete a single remote laboratory-based session using the SmartManage web system over 2 hours to provide real-time feedback regarding basic website function and technical support for final refinements to the intervention.
STAGE II: Patients complete a questionnaire over 30 minutes at baseline. Patients are randomized to 1 of 2 arms.
ARM I (SMARTMANAGE PROGRAM): Patients complete the cognitive behavioral stress and self-management (CBSM) intervention over 10 weeks during which they are taught and discuss a new stress reduction technique over the first 30 minutes and focus on stress- and self-management over the last 60 minutes. Patients receive a workbook with all the relaxation and stress management instructions, homework, self-monitoring tools and exercises to implement skills learned in the CBSM sessions in their own “real world” settings. After completion of the 10-week intervention, patients complete an online exit questionnaire over 30 minutes.
ARM II (EDUCATIONAL PROGRAM): Patients review up 10 educational web-based modules (1 per week) covering educational topics such as HIV and cancer co-management, communication, partnering with healthcare providers, and sex and intimacy, and attend 10 live group sessions (1 per week) where they conduct exercises to build skills and reduce stress, and receive education on cancer and HIV. After completion of the 10-week intervention, patients complete an online exit questionnaire over 30 minutes.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorFrank J. Penedo