Cognitive Behavioral Stress Management for HIV/AIDS and Cancer

(C-SmartManage Trial)

Overseen By Sara St. George, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Leukemia, Brain cancer, Severe mental illness, Alcohol dependence, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a stress management program specifically designed for Latino sexual minority men living with both HIV and cancer. The goal is to determine if this web-based program, called Culturally-tailored Cognitive Behavioral Stress Management, can reduce stress and improve health outcomes for those facing these challenges. Participants will engage in a 10-week program tailored to their cultural needs. It suits individuals who have had a non-spreading form of solid tumor cancer, are no longer in active treatment like chemotherapy, are living with HIV, and have a stable internet connection. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance stress management for others in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for Latino sexual minority men living with HIV and cancer?

Research has shown that Cognitive Behavioral Stress Management (CBSM) is generally safe for people with HIV and cancer. Studies with similar groups have found that CBSM is well-tolerated, with participants reporting no major side effects. This includes individuals from various backgrounds, such as racial and ethnic minorities. The goal is to help people manage stress with techniques that can improve well-being without causing harm.

This study tests a web-based version of CBSM designed specifically for Latino men. While researchers continue to evaluate this online format, the CBSM techniques themselves have a history of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Culturally-tailored Cognitive Behavioral Stress Management (CBSM) is unique because it specifically addresses the cultural needs and perspectives of Latino men living with HIV/AIDS and cancer. While traditional stress management techniques might not consider cultural nuances, this approach integrates culturally relevant practices and insights, making it more relatable and potentially more effective for this group. Researchers are excited about this treatment because it could lead to better mental health outcomes by fostering a stronger connection and engagement with the participants' cultural identities, which is often missing in standard stress management programs.

What evidence suggests that this culturally-tailored CBSM is effective for stress management in Latino sexual minority men with HIV and cancer?

Research has shown that Cognitive Behavioral Stress Management (CBSM) can reduce stress and improve mental health. In past studies, CBSM successfully lowered anxiety and depression in individuals with health issues such as lung cancer. This makes it a promising method for managing stress in people with HIV and cancer. In this trial, participants will receive a culturally-tailored version of CBSM designed for Latino sexual minority men, focusing on issues like dealing with stigma related to HIV and cancer. This tailored approach aims to address specific challenges and enhance overall well-being for this group. ^{1 2 4 6 7}

Who Is on the Research Team?

Sara M St. George, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Latino sexual minority men over the age of 18, living with HIV and non-metastatic solid tumor cancer, who are past their primary cancer treatment. Participants must have internet access and be fluent in English. Those with a life expectancy under 12 months, active severe mental illness or substance dependence, or certain types of cancers (like leukemia or brain cancer) cannot join.

Inclusion Criteria

I have been diagnosed with HIV.

It's been over 30 days since my last main cancer treatment.

I identify as a sexual minority man.

Exclusion Criteria

I have had leukemia, non-melanoma skin cancer, brain cancer, eye cancer, or a pediatric cancer as my only cancer diagnosis.

I have or am being treated for advanced cancer.

My doctor expects I have less than 12 months to live due to my health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention

4 weeks

Web-based sessions

Follow-up

Participants are monitored for stress, distress, and quality of life after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Stress Management
• Culturally-tailored Cognitive Behavioral Stress Management

Trial Overview The study tests a web-based cognitive behavioral stress management program tailored for Latino sexual minority men with HIV and cancer. It compares this specialized version to a standard one over one year to see if it better reduces health disparities related to distress from their diagnoses.

How Is the Trial Designed?

Group I: Culturally-tailored CBSM Experimental Treatment 1 Intervention

Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Cognitive-behavioral stress management (CBSM) significantly reduced anxiety and depression levels in 172 non-small cell lung cancer patients over a 10-week intervention, with improvements observed at both 3 and 6 months post-treatment.

Patients receiving CBSM reported enhanced quality of life, with increased global health status and function scores, particularly benefiting those with baseline depression or undergoing additional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety, depression, and quality of life in postoperative non-small cell lung cancer patients under the intervention of cognitive-behavioral stress management. Wang, F., Zhang, S., Song, B., et al.[2023]

Cognitive-behavioral stress management (CBSM) significantly reduces negative feelings and intrusive thoughts while increasing positive emotions in breast cancer patients who experience high levels of cancer-specific distress after surgery, based on a study of 240 patients over 12 months.

Patients with lower initial distress did not benefit from CBSM, suggesting that targeting psychosocial interventions to those with higher distress levels could enhance the effectiveness and efficiency of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential psychological effects of cognitive-behavioral stress management among breast cancer patients with high and low initial cancer-specific distress. Wang, AW., Bouchard, LC., Gudenkauf, LM., et al.[2023]

Cognitive-behavioral stress management (CBSM) has been shown to significantly improve relaxation, positive affect, and benefit finding in breast cancer patients, based on a meta-analysis of 18 randomized controlled trials involving 2564 participants.

CBSM effectively reduces anxiety, depression, and negative mood, while also lowering serum cortisol levels, indicating its potential to help patients cope with the stress of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Cognitive-Behavioral Stress Management for Breast Cancer Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Tang, M., Liu, X., Wu, Q., et al.[2021]

Cognitive-behavioral stress management (CBSM) training did not lead to improvements in clinical outcomes, such as HIV-1 surrogate markers or adherence to therapy, in a study of 104 HIV-infected individuals over 12 months.

However, CBSM significantly improved quality of life and reduced symptoms of anxiety and depression, particularly in participants who experienced high psychological distress at the start of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral stress management on HIV-1 RNA, CD4 cell counts and psychosocial parameters of HIV-infected persons. Berger, S., Schad, T., von Wyl, V., et al.[2018]

The Seren@ctif program, a digital self-help stress management tool, showed high acceptability and satisfaction among 10 patients with adjustment disorder and anxiety, with an average satisfaction score of 4 out of 5.

Participants experienced a significant reduction in anxiety symptoms, as measured by the STAI-State, with scores decreasing from 53.4 to 44.2 after completing the 5-week program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program]. Servant, D., Rougegrez, L., Barasino, O., et al.[2018]

The CBSM+ intervention, which included stress management and cognitive-behavioral techniques, significantly reduced depression scores in disadvantaged minority women living with AIDS after a 10-week program.

The positive effects of the CBSM+ intervention were sustained for one year, indicating its long-term efficacy in improving mental health outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased depression up to one year following CBSM+ intervention in depressed women with AIDS: the smart/EST women's project. Laperriere, A., Ironson, GH., Antoni, MH., et al.[2018]

The paper outlines the importance of adapting clinical interventions, like cognitive behavioral stress management (CBSM), to be culturally sensitive for HIV+ individuals, enhancing their relevance and effectiveness.

This approach aligns with NIH priorities for ecological validity and translational research, emphasizing the need to linguistically and culturally translate interventions to better serve diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Context and common ground: cultural adaptation of an intervention for minority HIV infected individuals. Dévieux, JG., Malow, RM., Rosenberg, R., et al.[2018]

An online cognitive behavioral stress management intervention for early-stage breast cancer survivors significantly improved self-efficacy in coping with cancer and regulating negative mood after 10 weeks compared to a waitlist control group.

Participants in the intervention group also reported lower levels of cancer-related post-traumatic symptoms, indicating that this online approach can effectively support psychological well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. Carpenter, KM., Stoner, SA., Schmitz, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03993054

Web-Based Cognitive Behavioral Stress Management for ... The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer. Official Title. Web-Based Cognitive ...

2. link.springer.com link.springer.com/article/10.1007/s10461-025-04945-y

Cultural Adaptation of a Web-Based Cognitive Behavioral ... This tailored version of CBSM included topics such as navigating the stigma associated with HIV and cancer, recognizing and managing chronic ...

3. researchprotocols.org researchprotocols.org/2022/7/e37822/

An Adapted Cognitive Behavioral Stress and Self ... An Adapted Cognitive Behavioral Stress and Self-management Intervention for Sexual Minority Men Living With HIV and Cancer Using the SmartManage ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9345025/

An Adapted Cognitive Behavioral Stress and Self ... Older people with HIV experience a higher incidence of cancer and other comorbidities; these burdens along with sexual minority stress can ...

5. withpower.com withpower.com/trial/phase-hiv-infections-10-2021-66141

Cognitive Behavioral Stress Management for HIV/AIDS and ... It has also been effective in reducing anxiety and depression in lung cancer patients, suggesting it may be beneficial for managing stress and improving mental ...

6. researchprotocols.org researchprotocols.org/2022/7/e37822

An Adapted Cognitive Behavioral Stress and Self ... Older people with HIV experience a higher incidence of cancer and other comorbidities; these burdens along with sexual minority stress can ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3670138/

Cognitive-Behavioral Stress Management and ... These findings suggest that racial/ethnic minority women with HIV at risk for cervical cancer who were randomized to a 10-week CBSM group experienced enhanced ...