Cancer, HIV/AIDS
Conditions
Brief summary
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.
Interventions
BEHAVIORALCulturally-tailored cognitive behavioral stress management
The SmartManage CBSM intervention includes content that is of clinical relevance to sexual minority men dually diagnosed with HIV and cancer. Intervention content includes: co-management of HIV and cancer, strategies for self-advocacy, partnering with the health system and health providers, intimacy and disclosure concerns regarding both conditions, and contextual stressors (e.g., racial/ethnic minority status), stigmatization, assertiveness and communication skills, and self-efficacy in care coordination. Participants receive weekly 1.5 hour interactive group sessions online that focus on stress and self-management skill-building, and also receive access to didactic information regarding intervention content via the intervention website. Intervention length is 10 weeks. This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in General Stress | 10 weeks | 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. |
| Change in Disease-Related Distress | 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. |
| Change in Health-Related Quality of Life (FACT-G) | 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. |
| Change in Health-Related Quality of Life (MOS-HIV) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Sixteen adults signed informed consent form and were allocated to the intervention. PI removed one from the study for providing false information.
Participants by arm
| Arm | Count |
|---|---|
| Culturally-tailored CBSM Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | PI Decision | 1 |
Baseline characteristics
| Characteristic | Culturally-tailored CBSM |
|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 11.4 |
| Disease-Related Distress Avoidance | 12.9 units on a scale STANDARD_DEVIATION 6.7 |
| Disease-Related Distress Hyperarousal | 8.0 units on a scale STANDARD_DEVIATION 6 |
| Disease-Related Distress Intrusion | 11.7 units on a scale STANDARD_DEVIATION 7.3 |
| Disease-Related Distress Total Score | 32.6 units on a scale STANDARD_DEVIATION 18.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| General Stress | 31.7 units on a scale STANDARD_DEVIATION 8.4 |
| Health Related Quality of Life (FACT-G) Emotional Well-being | 15.5 units on a scale STANDARD_DEVIATION 4.2 |
| Health Related Quality of Life (FACT-G) Functional Well-being | 16.9 units on a scale STANDARD_DEVIATION 6.4 |
| Health Related Quality of Life (FACT-G) Physical Well-being | 20.3 units on a scale STANDARD_DEVIATION 6.5 |
| Health Related Quality of Life (FACT-G) Social Well-being | 16.1 units on a scale STANDARD_DEVIATION 6.8 |
| Health Related Quality of Life (FACT-G) Total Score | 68.9 units on a scale STANDARD_DEVIATION 15.7 |
| Health Related Quality of Life (MOS-HIV) Cognitive Functioning | 17.9 units on a scale STANDARD_DEVIATION 5.2 |
| Health Related Quality of Life (MOS-HIV) General Health | 14.4 units on a scale STANDARD_DEVIATION 5.4 |
| Health Related Quality of Life (MOS-HIV) Health Distress | 17.3 units on a scale STANDARD_DEVIATION 5 |
| Health Related Quality of Life (MOS-HIV) Health Perception | 3.2 units on a scale STANDARD_DEVIATION 1.1 |
| Health Related Quality of Life (MOS-HIV) Mental Health | 19.9 units on a scale STANDARD_DEVIATION 3.9 |
| Health Related Quality of Life (MOS-HIV) Pain | 8.5 units on a scale STANDARD_DEVIATION 2.3 |
| Health Related Quality of Life (MOS-HIV) Physical Functioning | 13.7 units on a scale STANDARD_DEVIATION 3.7 |
| Health Related Quality of Life (MOS-HIV) Role Functioning | 2.7 units on a scale STANDARD_DEVIATION 1.1 |
| Health Related Quality of Life (MOS-HIV) Social Functioning | 4.4 units on a scale STANDARD_DEVIATION 1.7 |
| Health Related Quality of Life (MOS-HIV) Vitality/Energy | 13.8 units on a scale STANDARD_DEVIATION 3.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Change in Disease-Related Distress
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.
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Culturally-tailored CBSM | Change in Disease-Related Distress | Intrusion | -3.2 units on a scale | Standard Deviation 6.4 |
| Culturally-tailored CBSM | Change in Disease-Related Distress | Avoidance | -5.0 units on a scale | Standard Deviation 7.2 |
| Culturally-tailored CBSM | Change in Disease-Related Distress | Hyperarousal | -1.9 units on a scale | Standard Deviation 6.2 |
| Culturally-tailored CBSM | Change in Disease-Related Distress | Total Score | -10.2 units on a scale | Standard Deviation 17.8 |
Primary
Change in General Stress
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.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally-tailored CBSM | Change in General Stress | -1.8 units on a scale | Standard Deviation 10 |
Primary
Change in Health-Related Quality of Life (FACT-G)
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.
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (FACT-G) | Physical Well-being | -1.5 units on a scale | Standard Deviation 8 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (FACT-G) | Social Well-being | 0.2 units on a scale | Standard Deviation 4.3 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (FACT-G) | Emotional Well-being | 3.5 units on a scale | Standard Deviation 3.8 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (FACT-G) | Functional Well-being | 0.4 units on a scale | Standard Deviation 3.9 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (FACT-G) | Total Score | 2.7 units on a scale | Standard Deviation 12.1 |
Primary
Change in Health-Related Quality of Life (MOS-HIV)
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.
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Pain | -1 units on a scale | Standard Deviation 2.4 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Physical Functioning | -0.2 units on a scale | Standard Deviation 4.7 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Social Functioning | -0.2 units on a scale | Standard Deviation 2.5 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Role Functioning | 0.6 units on a scale | Standard Deviation 0.8 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Mental Health | 0.7 units on a scale | Standard Deviation 6.3 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Health Distress | -2.5 units on a scale | Standard Deviation 8.5 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Cognitive Functioning | -1.3 units on a scale | Standard Deviation 6.3 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Vitality/Energy | -0.8 units on a scale | Standard Deviation 3.8 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | General Health | 0.8 units on a scale | Standard Deviation 5 |
| Culturally-tailored CBSM | Change in Health-Related Quality of Life (MOS-HIV) | Health Perception | 0.3 units on a scale | Standard Deviation 0.8 |