Testing the Effect of Mindfulness for Prostatectomy Outcomes (TEMPO)

University of Michigan Rogel Cancer Center

Status: Terminated

Conditions: Prostate Cancer

Treatments: Behavioral: Mindfulness-based Intervention; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04727710

HUM00152158 (Other Identifier)

UMCC 2018.129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Part 2: Couples-based mindfulness intervention

Experimental group

Description:

Mindfulness-based intervention + Usual care

Treatment:

Behavioral: Usual Care

Behavioral: Mindfulness-based Intervention

Part 2: Usual care

Active Comparator group

Description:

Usual care

Treatment:

Behavioral: Usual Care