Mind-Body Health in Uro-Oncology: Research Study

Prostate Cancer Clinical Trial

Official title:

Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852030
• Other study ID #: EH09-202
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: June 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Text or email message
Text or email messages sent to research participants

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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