Mindfulness Education in Reducing Active Surveillance Stress in Participants with Prostate Cancer and Their Spouses

Status: Active

Description

This trial studies how well mindfulness education works in reducing surveillance stress in participants with prostate cancer and their spouses. Mindfulness education may help to reduce the effects of active surveillance stress, uncertainty, and rumination.

Eligibility Criteria

Inclusion Criteria

  • Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance) * While AS criteria for each program varies slightly, all programs use the following clinical and pathological criteria: ** Clinical stage T1c or T2a prostate cancer, verified by a participating urologist ** Diagnosis of prostate cancer made on a 12 core needle biopsy (if any of this information was unavailable prior to consent or on the diagnostic biopsy report, the eligibility was contingent on either urologist review of the diagnostic biopsy or the pathological data from the confirmation biopsy) ** Biopsy Gleason score =< 6 OR Gleason score 7 (3+4 ONLY), with =< 3 cores positive
  • Must be able to read, write, speak and understand English
  • Must be able to perform basic activities of daily living (as determined by referring study recruiter at intake)
  • Must be cognitively intact and free of serious psychiatric illness (as determined by study recruiter at intake)

Exclusion Criteria

  • Unable to provide consent
  • Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship

Locations & Contacts

Illinois

Chicago
Northwestern University
Status: Active
Contact: David Victorson
Phone: 847-467-3060
Email: d-victorson@northwestern.edu
University of Chicago Comprehensive Cancer Center
Status: Approved
Contact: Scott E. Eggener
Phone: 773-702-5195
Evanston
NorthShore University HealthSystem
Status: Active
Contact: Kristian Robert Novakovic
Phone: 847-999-4156

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Todd M. Morgan
Phone: 734-647-8903

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Contact: Alexander Kutikov
Phone: 888-369-2427

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Examine longitudinal change in positive and negative psychological responses to active surveillance (AS) between groups over time.

SECONDARY OBJECTIVES:

I. Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.

TERTIARY OBJECTIVES:

I. Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.

OUTLINE: Participants are randomized into 1 of 2 groups.

Before starting the course intervention, participants complete a baseline assessment.

GROUP A: Participants attend Health Promotion courses (Mindfulness Health Promotion) over 9 weeks (1 hour orientation, 8 weekly 2.5 hour sessions, 1 4-hour retreat) and complete individual exercises for homework over 35 minutes 6 days per week. Participants also receive weekly eHealth email messages with information relevant to the course learning objectives.

GROUP B: Participants attend Health Promotion courses (HealthPro) over 9 weeks (1 hour orientation, 8 weekly 2.5 hour sessions, 1 4-hour retreat) and complete individual exercises for homework over 35 minutes 6 days per week. Participants also receive weekly eHealth email messages with information relevant to the course learning objectives.

After completion of study, participants are followed up at 8 weeks, 6 months, and 12 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Northwestern University

Principal Investigator
David Victorson

Trial IDs

Primary ID NCI 16CC11
Secondary IDs NCI-2018-00889, STU00105259
Clinicaltrials.gov ID NCT02871752