Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)

Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)

This research project has 2 parts: The first part of the research is to develop a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. The second part is the trial registered here, which will pilot the researchers' mindfulness intervention, developed in part 1, and observe any reduction of distress for men undergoing prostatectomy and their partners.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Mindfulness-based Intervention; Behavioral: Usual Care

Detailed Description

In part 1 of this research, researchers developed a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. Three patients who had previously undergone prostatectomy, and had expressed interest in participating in future research endeavors, and their partners were recruited to inform the design of the intervention. This group of six stakeholders identified the types of distress experienced by newly diagnosed prostate cancer patients and their partners, as well as their favored intervention approaches. These stakeholders do participate in the intervention or control groups in part 2 of this study.

Researchers used thematic analysis to assess the type of distress identified by stakeholders as well as approaches favored by them. They mapped these themes on the available mindfulness approaches, identified in their review, to develop an intervention that best captures the concerns of prostate cancer survivors and partners.

Part 2 is the pilot study. Researchers will enroll 20 more couples (men who are planning to undergo radical prostatectomy and their partners) to participate in a pilot study of the intervention. The pilot study will have 2 cohorts (groups). Half of the couples will be randomly assigned to the mindfulness intervention (intervention group) and the other half will receive the usual care (control group). All participants in the intervention and control groups in part 2 of the study will be analyzed to determine the effects and feasibility of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Part 2--Pilot study:

Inclusion Criteria

• Patients aged 35 - 90 who are planning to undergo radical prostatectomy at University of Michigan Hospital
• Partners of these men, aged 18 and older

Exclusion Criteria:

• Participants cannot be less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 2: Couples-based mindfulness intervention; Mindfulness-based intervention + Usual care	Behavioral: Mindfulness-based Intervention; A self-directed, web-based mindfulness training. Investigators recommend one module a week for 6 weeks. Each module is approximately 1 hour long and consists of didactic components as well as meditation and mindfulness exercises.; Behavioral: Usual Care; Standard pre-operative survivorship seminar, offered monthly to all patients at Michigan Medicine about to undergo prostatectomy and their partners is aimed at promoting realistic expectations of prostatectomy outcomes, typical side effects, rehabilitation and emotional adjustment.
Active Comparator: Part 2: Usual care; Usual care	Behavioral: Usual Care; Standard pre-operative survivorship seminar, offered monthly to all patients at Michigan Medicine about to undergo prostatectomy and their partners is aimed at promoting realistic expectations of prostatectomy outcomes, typical side effects, rehabilitation and emotional adjustment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of distress assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Anxiety	This survey is administered as part of the patient's standard clinical care at University of Michigan. PROMIS SF Anxiety is an 8 item scale, each item is scored 1-5 where 1 is never and 5 is always. Higher scores indicate higher levels of anxiety.	Change from baseline at 3 and 6 months post-prostatectomy
Change in level of distress assessed using the PROMIS SF Depression.	This survey is administered as part of the patient's standard clinical care at University of Michigan. PROMIS SF Depression is an 8 item scale, each item is scored 1-5 where 1 is never and 5 is always. Higher scores indicate higher levels of depression.	Change from baseline at 3 and 6 months post-prostatectomy
Change in level of distress assessed using the PROMIS SF Positive Affect and Well Being	This survey is administered as part of the patient's standard clinical care at University of Michigan. PROMIS SF Positive Affect and Well Being is an 8 item scale, each item is scored 1-5 where 1 is never and 5 is always. Higher scores indicate higher levels of positive affect and well being.	Change from baseline at 3 and 6 months post-prostatectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in salivary cortisol level (only patients will complete this, not partners)	Saliva is collected through an at home collection kit that is mailed to the lab.	Change from baseline at 3 months post-prostatectomy
Change in level of distress assessed using the National Comprehensive Cancer Network (NCCN) Distress Thermometer	The NCCN Distress Thermometer is a 1-item global screener of distress using a 0-10 scale with 10 being most distressed.	Change from baseline to 3 months post-prostatectomy
Change in level of distress assessed using the 5-facet Mindfulness Questionnaire (FFMQ)	FFMQ is a 15 item self-reported assessment of mindfulness. Each item is scored 1-5, with higher scores indicating higher use of 5 key facets of mindfulness: Observing; Describing; Acting with awareness; Non-judging; Non-reactivity.	Change from baseline at 3 months post-prostatectomy
Change in urinary and sexual function assessed using Michigan Urological Surgery Improvement Collaborative (MUSIC) Expanded Prostate Cancer Index Composite (EPIC-26)	MUSIC's EPIC-26 is a 26-item survey. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing higher levels of continence and better erectile function.	Change from baseline at 3 and 6 months post-prostatectomy

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Lindsey Herrel, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): August 26, 2020
• Study Completion (Actual): August 26, 2020

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UMCC 2018.129; HUM00152158 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No