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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
Text or email messages sent to research participants
Northwestern University
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, 8 weeks, 6 months, 12 months
change in mindfulness using the 5-Facet Mindfulness Sub-scales
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Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
Time frame: baseline, 8 weeks, 6 months, 12 months