Testing the Effect of Mindfulness for Prostatectomy Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Mindfulness-based Intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 2: Couples-based mindfulness intervention<br>Mindfulness-based intervention + Usual care | Behavioral: Mindfulness-based Intervention<br>* 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.<br>Behavioral: Usual Care<br>* 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.<br>|
| Active Comparator: Part 2: Usual care<br>Usual care | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness