Mind-Body Health in Uro-Oncology: Research Study

NCT03852030 | Completed

• 1 other identifier: EH09-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer; Kidney Cancer; Bladder Cancer

Keywords

prostate cancer; mindfulness; eHealth; kidney cancer; bladder cancer; caregiver

Outcome Measures

Primary Outcomes (7)

• 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

  baseline, 8 weeks, 6 months, 12 months

• 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

  baseline, 8 weeks, 6 months, 12 months

• 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

  baseline, 8 weeks, 6 months, 12 months

• 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

  baseline, 8 weeks, 6 months, 12 months

• 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

  baseline, 8 weeks, 6 months, 12 months

• 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

  baseline, 8 weeks, 6 months, 12 months

• 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

  baseline, 8 weeks, 6 months, 12 months

Study Arms (3)

Mindfulness text/email message

EXPERIMENTAL

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

Health promotion text/email message

PLACEBO COMPARATOR

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

No text/email message

NO INTERVENTION

No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group.

Interventions

Text or email message BEHAVIORAL

Text or email messages sent to research participants

Health promotion text/email message; Mindfulness text/email message

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old or older
• Proficient in comprehending spoken English. Proficient in reading and writing English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Endeavor Health: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

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MeSH Terms

Conditions

Prostatic Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases

Study Officials

• David E Victorson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: February 22, 2019
• Study Start: July 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)