Back to resultsMind-Body Health in Uro-Oncology: Research Study
Primary Purpose
Prostate Cancer, Kidney Cancer, Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text or email message
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, mindfulness, eHealth, kidney cancer, bladder cancer, caregiver
Eligibility 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.
Sites / Locations
- Northwestern University
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Mindfulness text/email message
Health promotion text/email message
No text/email message
Arm Description
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.
Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress.
No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group.
Outcomes
Primary Outcome Measures
change in fatigue using the PROMIS Fatigue questionnaire
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
change in depression using the PROMIS Depression questionnaire
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
change in anxiety using the PROMIS Anxiety questionnaire
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
change in sleep using the PROMIS Sleep Disturbance questionnaire
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
change in physical function using the PROMIS Physical Function questionnaire
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
change in stress using the State-Based Stress Visual Analogue Scale
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
change in mindfulness using the 5-Facet Mindfulness Sub-scales
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
Secondary Outcome Measures
Full Information
NCT ID
NCT03852030
First Posted
December 12, 2018
Last Updated
June 12, 2023
Sponsor
Northwestern University
Collaborators
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT03852030
Brief Title
Mind-Body Health in Uro-Oncology: Research Study
Official Title
Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
NorthShore University HealthSystem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Kidney Cancer, Bladder Cancer
Keywords
prostate cancer, mindfulness, eHealth, kidney cancer, bladder cancer, caregiver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness text/email message
Arm Type
Experimental
Arm Description
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.
Arm Title
Health promotion text/email message
Arm Type
Placebo Comparator
Arm Description
Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress.
Arm Title
No text/email message
Arm Type
No Intervention
Arm Description
No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group.
Intervention Type
Behavioral
Intervention Name(s)
Text or email message
Intervention Description
Text or email messages sent to research participants
Primary Outcome Measure Information:
Title
change in fatigue using the PROMIS Fatigue questionnaire
Description
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
Time Frame
baseline, 8 weeks, 6 months, 12 months
Title
change in depression using the PROMIS Depression questionnaire
Description
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
Time Frame
baseline, 8 weeks, 6 months, 12 months
Title
change in anxiety using the PROMIS Anxiety questionnaire
Description
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
Time Frame
baseline, 8 weeks, 6 months, 12 months
Title
change in sleep using the PROMIS Sleep Disturbance questionnaire
Description
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
Time Frame
baseline, 8 weeks, 6 months, 12 months
Title
change in physical function using the PROMIS Physical Function questionnaire
Description
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
Time Frame
baseline, 8 weeks, 6 months, 12 months
Title
change in stress using the State-Based Stress Visual Analogue Scale
Description
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
Time Frame
baseline, 8 weeks, 6 months, 12 months
Title
change in mindfulness using the 5-Facet Mindfulness Sub-scales
Description
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
Time Frame
baseline, 8 weeks, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Victorson, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mind-Body Health in Uro-Oncology: Research Study
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