← Back to Search

Stress Management Therapy for Prostate Cancer

N/A
Waitlist Available
Led By Frank Penedo, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0)
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 3, baseline to month 6, baseline to month 12
Awards & highlights

Study Summary

This trial will study the effects of a 10-week stress management program on quality of life, distress, depression, and physical health in Spanish-speaking, Hispanic/Latino men diagnosed with Prostate Cancer.

Who is the study for?
This trial is for Spanish-speaking Hispanic/Latino men over 18 with localized Prostate Cancer who've had surgery or radiation treatment between 4 and 72 months ago. They should be willing to participate in a stress management program and follow-up for about a year. Men with recent severe mental illness, active substance or alcohol dependence, certain immune conditions, or other cancers within the last two years are excluded.Check my eligibility
What is being tested?
The study tests a 10-week group program focused on managing emotions and stress through relaxation and coping strategies. It aims to improve quality of life, reduce distress and depression, and enhance physical health after prostate cancer diagnosis.See study design
What are the potential side effects?
Since this trial involves psychological support rather than medication, there may not be direct side effects like those seen with drugs. However, discussing sensitive topics could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer is localized and not spread to lymph nodes or other parts.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 3, baseline to month 6, baseline to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 3, baseline to month 6, baseline to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Change in HRQoL as measured by the PROMIS Fatigue questionnaire
Change in HRQoL as measured by the PROMIS Pain questionnaire
+2 more
Secondary outcome measures
Change in interpersonal function as measured the SIP questionnaire
Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section I-II
Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section III
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cultural-Cognitive Behavioral Stress Management (CCBSM)Experimental Treatment1 Intervention
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Group II: Cognitive Behavioral Stress Management (CBSM)Active Control1 Intervention
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
898 Previous Clinical Trials
409,451 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,031 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,953 Total Patients Enrolled
1 Trials studying Prostate Disease
7 Patients Enrolled for Prostate Disease

Media Library

Cultural CBSM Clinical Trial Eligibility Overview. Trial Name: NCT03344757 — N/A
Prostate Disease Research Study Groups: Cultural-Cognitive Behavioral Stress Management (CCBSM), Cognitive Behavioral Stress Management (CBSM)
Prostate Disease Clinical Trial 2023: Cultural CBSM Highlights & Side Effects. Trial Name: NCT03344757 — N/A
Cultural CBSM 2023 Treatment Timeline for Medical Study. Trial Name: NCT03344757 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently recruiting participants?

"Indeed, the clinical trails website verifies that this medical trial is in search of participants. The study was first posted on October 5th 2017 and experienced an update as recent as September 16th 2022. 200 individuals are sought from a single centre."

Answered by AI

To what extent are individuals engaging in this research?

"Affirmative. The information on clinicaltrials.gov confirms that this medical trial is currently accepting patients. Initially listed on October 5th 2017, it has since been modified as recently as September 16 2022. 200 participants need to be enrolled across 1 centre for the experiment to continue."

Answered by AI

What are the goals of this research endeavor?

"During this medical trial, the primary outcome to be evaluated over a Baseline to Month 3, Baseline to Month 6, and Baseline to Month 12 time frame is Change in symptom burden as measured by EPIC-UIN. Subsidiary outcomes include shifts in psychosocial distress (PROMIS Depression questionnaire), interpersonal function (SIP Questionnaire), and prostate cancer-specific psychological distress (MAX-PC - Section III)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Health Gatherings - For Your Health After Cancer
Frank Penedo 2017. "Health Gatherings - For Your Health After Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03344757.
All > Prostate Cancer Miami > Prostate
~7 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top