Mind-Body Health in Uro-Oncology: Research Study

NCT ID: NCT03852030

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Kidney Cancer Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.

Study Groups

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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.

Group Type EXPERIMENTAL

Text or email message

Intervention Type BEHAVIORAL

Text or email messages sent to research participants

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.

Group Type PLACEBO_COMPARATOR

Text or email message

Intervention Type BEHAVIORAL

Text or email messages sent to research participants

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text or email message

Text or email messages sent to research participants

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Endeavor Health

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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David Victorson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Victorson, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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Other Identifiers

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EH09-202

Identifier Type: -

Identifier Source: org_study_id

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