Trial Outcomes & Findings for Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer (NCT NCT03993054)

Last Updated: 2025-06-02

Results Overview

The Perceived Stress Scale (PSS) consists of 10 items, which are summed to create a total score ranging from 0 to 40. Higher scores indicate greater levels of perceived stress. The outcome was analyzed as the change from baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

10 weeks

Results posted on

2025-06-02

Participant Flow

Sixteen adults signed informed consent form and were allocated to the intervention. PI removed one from the study for providing false information.

Participant milestones

Participant milestones
Measure	Culturally-tailored CBSM Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Culturally-tailored CBSM Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Overall Study PI Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Culturally-tailored CBSM n=15 Participants Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Age, Continuous	51.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
General Stress	31.7 units on a scale STANDARD_DEVIATION 8.4 • n=5 Participants
Disease-Related Distress Intrusion	11.7 units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants
Disease-Related Distress Avoidance	12.9 units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants
Disease-Related Distress Hyperarousal	8.0 units on a scale STANDARD_DEVIATION 6.0 • n=5 Participants
Disease-Related Distress Total Score	32.6 units on a scale STANDARD_DEVIATION 18.2 • n=5 Participants
Health Related Quality of Life (FACT-G) Physical Well-being	20.3 units on a scale STANDARD_DEVIATION 6.5 • n=5 Participants
Health Related Quality of Life (FACT-G) Social Well-being	16.1 units on a scale STANDARD_DEVIATION 6.8 • n=5 Participants
Health Related Quality of Life (FACT-G) Emotional Well-being	15.5 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants
Health Related Quality of Life (FACT-G) Functional Well-being	16.9 units on a scale STANDARD_DEVIATION 6.4 • n=5 Participants
Health Related Quality of Life (FACT-G) Total Score	68.9 units on a scale STANDARD_DEVIATION 15.7 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Pain	8.5 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Physical Functioning	13.7 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Social Functioning	4.4 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Role Functioning	2.7 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Mental Health	19.9 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Health Distress	17.3 units on a scale STANDARD_DEVIATION 5.0 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Cognitive Functioning	17.9 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Vitality/Energy	13.8 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants
Health Related Quality of Life (MOS-HIV) General Health	14.4 units on a scale STANDARD_DEVIATION 5.4 • n=5 Participants
Health Related Quality of Life (MOS-HIV) Health Perception	3.2 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome measures
Measure	Culturally-tailored CBSM n=15 Participants Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Change in General Stress	-1.8 units on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: 10 weeks

The Impact of Events Scale-Revised (IES-R) measures the psychological impact of traumatic events. It consists of three subscales: intrusion (eight items), avoidance (eight items), and hyperarousal (six items). Each subscale score is calculated by summing the items within that subscale. The maximum possible score for intrusion and avoidance is 32 each, while hyperarousal has a maximum score of 24. The scores from these subscales are summed to create a total score, which ranges from 0 to 88. Higher scores indicate a greater negative impact of the traumatic event. The outcome was analyzed as the change from baseline.

Outcome measures

Outcome measures
Measure	Culturally-tailored CBSM n=15 Participants Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Change in Disease-Related Distress Intrusion	-3.2 units on a scale Standard Deviation 6.4
Change in Disease-Related Distress Avoidance	-5.0 units on a scale Standard Deviation 7.2
Change in Disease-Related Distress Hyperarousal	-1.9 units on a scale Standard Deviation 6.2
Change in Disease-Related Distress Total Score	-10.2 units on a scale Standard Deviation 17.8

PRIMARY outcome

Timeframe: 10 weeks

The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire was used to assess quality of life. It comprises four sub-scales: physical well-being (7 items, score range 0-28), social/family well-being (7 items, score range 0-28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). The overall score is calculated by summing the scores of these four sub-scales, resulting in a total possible score range of 0-108. Higher scores on the FACT-G indicate a better quality of life. The outcome was analyzed as the change from baseline.

Outcome measures

Outcome measures
Measure	Culturally-tailored CBSM n=15 Participants Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Change in Health-Related Quality of Life (FACT-G) Physical Well-being	-1.5 units on a scale Standard Deviation 8
Change in Health-Related Quality of Life (FACT-G) Social Well-being	0.2 units on a scale Standard Deviation 4.3
Change in Health-Related Quality of Life (FACT-G) Emotional Well-being	3.5 units on a scale Standard Deviation 3.8
Change in Health-Related Quality of Life (FACT-G) Functional Well-being	0.4 units on a scale Standard Deviation 3.9
Change in Health-Related Quality of Life (FACT-G) Total Score	2.7 units on a scale Standard Deviation 12.1

PRIMARY outcome

Timeframe: 10 weeks

The Medical Outcomes Study HIV Survey (MOS-HIV) assesses 10 health dimensions (i.e., health perceptions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy, health distress, and quality of life). Subscales are scored on a 0-100 scale, with a higher score indicating better health. The outcome was analyzed as the change from baseline.

Outcome measures

Outcome measures
Measure	Culturally-tailored CBSM n=15 Participants Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Change in Health-Related Quality of Life (MOS-HIV) Pain	-1 units on a scale Standard Deviation 2.4
Change in Health-Related Quality of Life (MOS-HIV) Physical Functioning	-0.2 units on a scale Standard Deviation 4.7
Change in Health-Related Quality of Life (MOS-HIV) Social Functioning	-0.2 units on a scale Standard Deviation 2.5
Change in Health-Related Quality of Life (MOS-HIV) Role Functioning	0.6 units on a scale Standard Deviation 0.8
Change in Health-Related Quality of Life (MOS-HIV) Mental Health	0.7 units on a scale Standard Deviation 6.3
Change in Health-Related Quality of Life (MOS-HIV) Health Distress	-2.5 units on a scale Standard Deviation 8.5
Change in Health-Related Quality of Life (MOS-HIV) Cognitive Functioning	-1.3 units on a scale Standard Deviation 6.3
Change in Health-Related Quality of Life (MOS-HIV) Vitality/Energy	-0.8 units on a scale Standard Deviation 3.8
Change in Health-Related Quality of Life (MOS-HIV) General Health	0.8 units on a scale Standard Deviation 5
Change in Health-Related Quality of Life (MOS-HIV) Health Perception	0.3 units on a scale Standard Deviation 0.8

Adverse Events

Culturally-tailored CBSM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara St. George

University of Miami

Phone: 305-243-0726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place