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SmartManage Stress Management for HIV+ Cancer Survivors

University of Miami logo

University of Miami

Status

Completed

Conditions

Cancer
Hiv
Stress

Treatments

Behavioral: SmartManage for HIV+ cancer survivors
Behavioral: Educational Control

Study type

Interventional

Funder types

Other

Identifiers

NCT04544917
20190762

Details and patient eligibility

About

The purpose of this study is to design and refine a web-based platform developed for managing symptom burden in men who have sex who are HIV+ cancer survivors.

Enrollment

32 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age: 18 years or older
  2. Fluent in English
  3. Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
  4. Be at least 30 days post active primary cancer treatment
  5. Self identify as a sexual minority cisgender man
  6. Self-report having been diagnosed with HIV
  7. Have reliable access to a computer/device with internet accessibility

Exclusion criteria

  1. Have had one of the following exclusionary cancer types: Non-melanoma skin cancer, brain cancer, eye cancer, history of some form of pediatric cancer (if that is participant's only cancer diagnosis)
  2. History of advanced (metastatic) cancer of any type
  3. Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
  4. Appears actively intoxicated or otherwise unable to provide full informed consent
  5. Have any other medical condition resulting in predicted live expectancy of less than 12 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

SmartManage Group
Experimental group
Description:
Participants in this group will receive ten 90-minute weekly therapist delivered SmartManage group sessions via video conference. Participants will have access to the SmartManage web platform, which will also guide the live intervention sessions.
Treatment:
Behavioral: SmartManage for HIV+ cancer survivors
Educational Control Group
Active Comparator group
Description:
Participants in this group will view ten weekly control content video recorded sessions.
Treatment:
Behavioral: Educational Control

Trial contacts and locations

1

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Central trial contact

Marc J Puccinelli, Ph.D.; Madeline Krause, MSEd

Data sourced from clinicaltrials.gov

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