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Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer (C-SmartManage)

University of Miami logo

University of Miami

Status

Completed

Conditions

Cancer
HIV/AIDS

Treatments

Behavioral: Culturally-tailored cognitive behavioral stress management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03993054
U54MD002266 (U.S. NIH Grant/Contract)
20200127

Details and patient eligibility

About

This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will use a single-group pre-post design. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer.

Enrollment

16 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Have been diagnosed with at least one form of non-metastatic solid tumor cancer,
  2. Are ≥ 30 days post active primary treatment (i.e. surgery, radiation, and/or chemotherapy*) for their cancer. (Note: Adjuvant therapies, such as hormone therapy for prostate cancer, etc. are not considered exclusionary),
  3. Self-identify as a sexual minority man,
  4. have been diagnosed with HIV,
  5. Have reliable access to a computer/device with internet accessibility, and
  6. Are fluent English.

Exclusion criteria

  1. Have had one of the following exclusionary cancer types: Leukemia (or other cancers of the blood), Non-melanoma skin cancer only (not in combination with another type listed in the inclusion criteria above), Brain cancer, Eye cancer, a form of pediatric cancer (if the pediatric cancer is the only cancer diagnosis the patient has had),
  2. Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer,
  3. Have had inpatient treatment for severe mental illness in the past 12 months, or have overt signs of psychopathology (i.e. psychosis) and/or suicidality at the time of screening,
  4. Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months,
  5. Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or
  6. Have any other medical conditions resulting in a predicted life expectancy <12 months.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Culturally-tailored CBSM
Experimental group
Description:
Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Treatment:
Behavioral: Culturally-tailored cognitive behavioral stress management

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Sara St. George, Ph.D.

Data sourced from clinicaltrials.gov

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