Mind-Body Health in Uro-Oncology: Research Study

June 12, 2023 updated by: David Victorson, Northwestern University

Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial

In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer
  • Spouses/significant others will only be included if their partners with cancer diagnoses will be participating
  • 18 years old or older
  • Proficient in comprehending spoken English. Proficient in reading and writing English.

Exclusion Criteria:

  • Is not able to receive email or text messages
  • History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated.
  • Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised.
  • Diminished cognitive skills as to render consent meaningless
  • Physical debilitation such that study participation would not be feasible or would create undue hardship.
  • Participation in the intervention arm of the preceding study, "Reducing Stress During Active Surveillance" EH09-202.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness text/email message

Weekly MBSR specific text or email messages related to course teachings were sent.

TYPES OF MESSAGES INCLUDED: Non-reaction; Non-Judgment; Awareness; Loving Kindness; Acceptance.
Behavioral: Text or email message
Text or email messages sent to research participants
Placebo Comparator: Health promotion text/email message
Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress.
Behavioral: Text or email message
Text or email messages sent to research participants
No Intervention: No text/email message
No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in fatigue using the PROMIS Fatigue questionnaire
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
baseline, 8 weeks, 6 months, 12 months
change in depression using the PROMIS Depression questionnaire
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
baseline, 8 weeks, 6 months, 12 months
change in anxiety using the PROMIS Anxiety questionnaire
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
baseline, 8 weeks, 6 months, 12 months
change in sleep using the PROMIS Sleep Disturbance questionnaire
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
baseline, 8 weeks, 6 months, 12 months
change in physical function using the PROMIS Physical Function questionnaire
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
baseline, 8 weeks, 6 months, 12 months
change in stress using the State-Based Stress Visual Analogue Scale
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
baseline, 8 weeks, 6 months, 12 months
change in mindfulness using the 5-Facet Mindfulness Sub-scales
Time Frame: baseline, 8 weeks, 6 months, 12 months
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
baseline, 8 weeks, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

NorthShore University HealthSystem

Investigators

  • Principal Investigator: David E Victorson, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH09-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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