Testing the Effect of Mindfulness for Prostatectomy Outcomes

NCT04727710 | Terminated

• 2 other identifiers: UMCC 2018.129HUM00152158
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

Part 2: Couples-based mindfulness intervention

EXPERIMENTAL

Mindfulness-based intervention + Usual care

Behavioral: Mindfulness-based Intervention; Behavioral: Usual Care

Part 2: Usual care

ACTIVE COMPARATOR

Usual care

Behavioral: Usual Care

Interventions

Mindfulness-based Intervention BEHAVIORAL

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.

Part 2: Couples-based mindfulness intervention

Usual Care BEHAVIORAL

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.

Part 2: Couples-based mindfulness intervention; Part 2: Usual care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 35 - 90 who are planning to undergo radical prostatectomy at University of Michigan Hospital
• Partners of these men, aged 18 and older

You may not qualify if:

• Participants cannot be less than 18 years of age

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lindsey Herrel, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: August 26, 2020
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)