Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change in level of distress assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Anxiety
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Part 2: Usual care
Usual care
Intervention: Usual Care (Behavioral)
Part 2: Couples-based mindfulness intervention
Mindfulness-based intervention + Usual care
Intervention: Mindfulness-based Intervention (Behavioral)
Part 2: Couples-based mindfulness intervention
Mindfulness-based intervention + Usual care
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Change in level of distress assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Anxiety
Time Frame: Change from baseline at 3 and 6 months post-prostatectomy
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 in level of distress assessed using the PROMIS SF Depression.
Time Frame: Change from baseline at 3 and 6 months post-prostatectomy
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 in level of distress assessed using the PROMIS SF Positive Affect and Well Being
Time Frame: Change from baseline at 3 and 6 months post-prostatectomy
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.
Secondary Outcomes
- Change in salivary cortisol level (only patients will complete this, not partners)(Change from baseline at 3 months post-prostatectomy)
- Change in level of distress assessed using the National Comprehensive Cancer Network (NCCN) Distress Thermometer(Change from baseline to 3 months post-prostatectomy)
- Change in level of distress assessed using the 5-facet Mindfulness Questionnaire (FFMQ)(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)(Change from baseline at 3 and 6 months post-prostatectomy)