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Mindfulness-based Intervention for Prostate Cancer (TEMPO Trial)

N/A
Waitlist Available
Led By Lindsey Herrel, MD, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 3 and 6 months post-prostatectomy
Awards & highlights

TEMPO Trial Summary

This trial will test a mindfulness intervention to help ease distress for men undergoing prostatectomy and their partners.

Eligible Conditions
  • Prostate Cancer

TEMPO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3 and 6 months post-prostatectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3 and 6 months post-prostatectomy 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 level of distress assessed using the PROMIS SF Depression.
Change in level of distress assessed using the PROMIS SF Positive Affect and Well Being
Change in level of distress assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Anxiety
Secondary outcome measures
Change in level of distress assessed using the 5-facet Mindfulness Questionnaire (FFMQ)
Change in level of distress assessed using the National Comprehensive Cancer Network (NCCN) Distress Thermometer
Change in salivary cortisol level (only patients will complete this, not partners)
+1 more

TEMPO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Couples-based mindfulness interventionExperimental Treatment2 Interventions
Mindfulness-based intervention + Usual care
Group II: Part 2: Usual careActive Control1 Intervention
Usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-based Intervention
2018
N/A
~780
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,096 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,985 Patients Enrolled for Prostate Cancer
Lindsey Herrel, MD, MSPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Testing the Effect of Mindfulness for Prostatectomy Outcomes
2020. "Testing the Effect of Mindfulness for Prostatectomy Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04727710.
~0 spots leftby Apr 2025
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