Health Gatherings - For Your Health After Cancer

Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer

Sponsors

Lead Sponsor: University of Miami

Collaborator: Northwestern University
National Cancer Institute (NCI)

Source University of Miami
Brief Summary

The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).

Overall Status Recruiting
Start Date 2017-10-05
Completion Date 2022-09-01
Primary Completion Date 2022-09-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in symptom burden as measure by EPIC-S. Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in HRQoL as measured by the FACT questionnaire. Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in symptom burden as measure by EPIC-UIN. Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in HRQoL as measured by the PROMIS Fatigue questionnaire Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in HRQoL as measured by the PROMIS Pain questionnaire Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Secondary Outcome
Measure Time Frame
Change in stress management skills as measured by MOCS-A Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section I-II Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section III Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in psychosocial distress as measured by the PROMIS Depression questionnaire Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in psychosocial distress as measured by the PROMIS Anxiety questionnaire Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in interpersonal function as measured the SIP questionnaire Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in the activation of leukocyte glucocorticoid receptors expression Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Change in the inflammatory gene expression Baseline to Month 3, Baseline to Month 6, Baseline to Month 12
Enrollment 260
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cultural CBSM

Description: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).

Arm Group Label: C-CBSM

Intervention Type: Behavioral

Intervention Name: Standard CBSM

Description: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.

Arm Group Label: CBSM

Eligibility

Criteria:

Inclusion Criteria: 1. ≥ 18 years of age; 2. Hispanic/Latino self-identification; 3. Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); 4. Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0); 5. Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months; 6. Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review; 7. Willingness to be randomized and followed for approximately12 months. Exclusion Criteria: 1. History of non-skin cancer within the last 5 years. 2. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review; 3. Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; 4. Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and 5. Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review. 6. Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review. .

Gender:

Male

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Frank Penedo, Ph.D. Principal Investigator University of Miami
Overall Contact

Last Name: Dolores M Perdomo, Ph.D.

Phone: 305-431-2574

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
University of Miami | Miami, Florida, 33136, United States Recruiting Dolores M Perdomo, PhD, LCSW 305-355-9057 [email protected] Frank Penedo, PhD Principal Investigator
Northwestern University | Chicago, Illinois, 60611, United States Completed
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Miami

Investigator Full Name: Frank Penedo

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: C-CBSM

Type: Experimental

Description: Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.

Label: CBSM

Type: Active Comparator

Description: Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News