Mind-Body Health in Uro-Oncology: Research Study
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 3 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal