NCT04727710

Testing the Effect of Mindfulness for Prostatectomy Outcomes

Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-26
• Primary completion: 2020-08-26
• Completion: 2020-08-26
• First posted: 2021-01-27
• Last updated: 2022-10-10

Locations

1 site across 1 country: United States