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Mind-Body Health in Uro-Oncology: Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852030
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
NorthShore University HealthSystem
Information provided by (Responsible Party):
David Victorson, Northwestern University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Kidney Cancer Bladder Cancer Behavioral: Text or email message Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Following participation in the 8-week course, participants will be randomized to either 4 months of: 1) weekly MBSR 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.
Masking: Single (Participant)
Masking Description: Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.
Primary Purpose: Supportive Care
Official Title: Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
Actual Study Start Date : July 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852030


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Northwestern University
NorthShore University HealthSystem
Investigators
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Principal Investigator: David E Victorson, PhD Northwestern University
More Information
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Publications:
Kabat-Zinn J. Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing; 1990
Bishop SR, Lau M, Shapiro S et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice 2004;11(3):230-241
Victorson D, Hankin V, Polster R, McCurdy M, McGuire M, Brendler C. Reducing Symptoms of Anxiety for Men with Prostate Cancer on Active Surveillance and their Spouses: Initial Findings from a Randomized Clinical Trial. The Journal of Urology 2010;138(4):e180-e181
Eyberg S, Edwards D, Boggs S, Foote R. Maintaining the Treatment Effects of Parent Training: The Role of Booster Sessions and Other Maintenance Strategies. Clinical Psychology: Science and Practice 1998;5:544-554
Gershon R. Comparing short forms and CAT across PROMIS. 2009

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Responsible Party: David Victorson, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03852030    
Other Study ID Numbers: EH09-202
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Victorson, Northwestern University:
prostate cancer
mindfulness
eHealth
 kidney cancer
bladder cancer
caregiver
Additional relevant MeSH terms:
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Prostatic Neoplasms
Urinary Bladder Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type