Clinical trial NCT04727710: Testing the Effect of Mindfulness for Prostatectomy Outcomes
Official title: Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Mindfulness
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in level of distress assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Anxiety
timeFrame: Change from baseline at 3 and 6 months post-prostatectomy
measure: Change in level of distress assessed using the PROMIS SF Depression.
timeFrame: Change from baseline at 3 and 6 months post-prostatectomy
measure: Change in level of distress assessed using the PROMIS SF Positive Affect and Well Being
timeFrame: Change from baseline at 3 and 6 months post-prostatectomy
Secondary outcomes:
measure: Change in salivary cortisol level (only patients will complete this, not partners)
timeFrame: Change from baseline at 3 months post-prostatectomy
measure: Change in level of distress assessed using the National Comprehensive Cancer Network (NCCN) Distress Thermometer
timeFrame: Change from baseline to 3 months post-prostatectomy
measure: Change in level of distress assessed using the 5-facet Mindfulness Questionnaire (FFMQ)
timeFrame: Change from baseline at 3 months post-prostatectomy
measure: Change in urinary and sexual function assessed using Michigan Urological Surgery Improvement Collaborative (MUSIC) Expanded Prostate Cancer Index Composite (EPIC-26)
timeFrame: Change from baseline at 3 and 6 months post-prostatectomy
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lindsey Herrel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: