Mind-Body Health in Uro-Oncology: Research Study

Not Applicable

Completed

• Conditions: Bladder Cancer; Prostate Cancer; Kidney Cancer
• Interventions: Behavioral: Text or email message

• Registration Number: NCT03852030
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health promotion text/email message	Text or email message	Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress.
Mindfulness text/email message	Text or 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.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States