Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- change in depression using the PROMIS Depression questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
change in depression using the PROMIS Depression questionnaire
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
change in anxiety using the PROMIS Anxiety questionnaire
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
change in sleep using the PROMIS Sleep Disturbance questionnaire
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
change in stress using the State-Based Stress Visual Analogue Scale
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
change in fatigue using the PROMIS Fatigue questionnaire
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
change in physical function using the PROMIS Physical Function questionnaire
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
change in mindfulness using the 5-Facet Mindfulness Sub-scales
时间窗: baseline, 8 weeks, 6 months, 12 months
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
次要结局
未报告次要终点
研究者
David Victorson
Associate Professor
Northwestern University