SmartManage Stress Management for HIV+ Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Development of an eHealth-based Cognitive Behavioral Stress and Self-Management Intervention to Reduce Symptom Burden in HIV+ Gay and Bisexual Men Who Have Sex With Men (MSM) Treated for Non-Metastatic Cancer

Conditions
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Cancer, Hiv, Stress

Intervention / Treatment
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* Behavioral: SmartManage for HIV+ cancer survivors
* Behavioral: Educational Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or older Fluent in English Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer Be at least 30 days post active primary cancer treatment Self identify as a sexual minority cisgender man Self-report having been diagnosed with HIV Have reliable access to a computer/device with internet accessibility Exclusion Criteria: 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) History of advanced (metastatic) cancer of any type Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk Appears actively intoxicated or otherwise unable to provide full informed consent Have any other medical condition resulting in predicted live expectancy of less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartManage Group<br>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. | Behavioral: SmartManage for HIV+ cancer survivors<br>* Ten weekly therapist delivered group sessions delivered via web conference. Sessions focus on cognitive behavioral stress management, psychoeducation, and management strategies for dual diagnosis of HIV and cancer. Participants will have access to the SmartManage web platform which has all intervention material, resources, and exercises.<br>|
| Active Comparator: Educational Control Group<br>Participants in this group will view ten weekly control content video recorded sessions. | Behavioral: Educational Control<br>* Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible SMM that agree to participate | Feasibility of the intervention will be reported as the proportion of eligible sexual minority men (SMM) who agree to participate versus decline | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| USE Questionnaire Scores | Acceptability of the intervention will be reported as Usefulness, Satisfaction and Ease of Use (USE) Questionnaire Scores. USE is a 30-item questionnaire with a total score ranging from 30-240 with the higher score indicating greater acceptability of the intervention. | Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom burden, Cognitive behavioral stress management, Intervention development