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Exercise + Cognitive Behavioral Therapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Neeraj Agarwal, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with advanced prostate cancer
A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question 'how tired did you feel in the past week?'
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 12 weeks post intervention (24 weeks)
Awards & highlights

Study Summary

This trial is studying how well exercise and/or internet-based cognitive behavior therapy help to reduce fatigue in men with prostate cancer.

Who is the study for?
This trial is for English-speaking men with advanced prostate cancer who are currently on hormone therapy and have felt tired in the past week. They should be sedentary, exercising less than 90 minutes per week, but physically able to start an exercise program and have internet access.Check my eligibility
What is being tested?
The study tests if exercise alone or combined with online cognitive behavior therapy can reduce fatigue in men with advanced prostate cancer. Participants will be randomly assigned to one of the interventions to compare effectiveness.See study design
What are the potential side effects?
Potential side effects may include typical exercise-related issues such as muscle soreness or strain. Cognitive behavior therapy is generally low-risk but could potentially cause temporary increases in distress due to self-reflection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with advanced prostate cancer.
Select...
I've felt tired, scoring at least 4 out of 10, in the past week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 weeks post intervention (24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 weeks post intervention (24 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fatigue
Secondary outcome measures
Change in Quality of Life
Change in activity level

Trial Design

2Treatment groups
Experimental Treatment
Group I: Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)Experimental Treatment2 Interventions
Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based CBT intervention over 12 weeks.
Group II: Exercise - Arm IExperimental Treatment1 Intervention
Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavior Therapy
2010
Completed Phase 3
~2630
Exercise Intervention
2016
Completed Phase 4
~1330

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,563 Total Patients Enrolled
1 Trials studying Sedentary Lifestyle
100 Patients Enrolled for Sedentary Lifestyle
Neeraj Agarwal, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
2 Previous Clinical Trials
42 Total Patients Enrolled
Benjamin Maughan, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03421782 — Phase 2
Sedentary Lifestyle Research Study Groups: Exercise - Arm I, Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)
Sedentary Lifestyle Clinical Trial 2023: Exercise Intervention Highlights & Side Effects. Trial Name: NCT03421782 — Phase 2
Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03421782 — Phase 2

Frequently Asked Questions

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

Is there still room for participants in this research project?

"Unfortunately, this particular clinical trial is no longer recruiting patients. Although it was first posted on February 26th, 2018 and last updated June 24th, 2022, there are many other trials with open enrollment that are currently running."

Answered by AI

How risky is it for patients to try the Exercise Intervention?

"While there is some evidence of safety, as this is a phase 2 trial, Power rates the Exercise Intervention program at a 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fatigue Interventions in Cancer (Exercise Intervention)
2018. "Fatigue Interventions in Cancer (Exercise Intervention)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03421782.
~18 spots leftby Apr 2025
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