Trials / Completed
CompletedNCT03852030
Mind-Body Health in Uro-Oncology: Research Study
Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Text or email message | Text or email messages sent to research participants |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2019-02-22
- Last updated
- 2023-06-13
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03852030. Inclusion in this directory is not an endorsement.