GI 1549: PROGRAMS TO SUPPORT YOU DURING CHEMOTHERAPY (PRO-YOU) A Randomized Controlled Pilot Study of Yoga Compared to an Attention Control in Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
研究概览
简要总结
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
详细描述
PRIMARY OBJECTIVES:
I. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.
SECONDARY OBJECTIVES:
I. To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.
II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
- •Have an Eastern Cooperative Oncology Group performance status of =< 1
- •Ability to understand and the willingness to sign and informed consent document in English
排除标准
- •Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
研究组 & 干预措施
Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
干预措施: Questionnaire Administration (Other)
Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
干预措施: Daily Survey Administration (Other)
Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
干预措施: Yoga Skills Training (Behavioral)
Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
干预措施: Actigraphy Assessment (Other)
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
干预措施: Laboratory Biomarker Analysis (Other)
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
干预措施: Questionnaire Administration (Other)
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
干预措施: Daily Survey Administration (Other)
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
干预措施: Attention Control (Behavioral)
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
干预措施: Actigraphy Assessment (Other)
结局指标
主要结局
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
时间窗: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
次要结局
- Psychological Stress Assessed by the PSS (Daily)(At 0-2 weeks and 8-10 weeks after start of intervention)
- Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)(At 0-2 weeks and 8-10 weeks after start of intervention)
- Circadian Disruption (Daily)(At 8-10 weeks after start of intervention)
- Circadian Disruption (Recalled)(At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention)
- Depressive Symptoms Assessed by PROMIS(At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention)
- Fatigue (Daily)(At 0-2 weeks and 8-10 weeks after start of intervention)
- Depressive Symptoms (Daily)(At 0-2 weeks and 8-10 weeks after start of intervention)
- Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits(At 10 weeks after start of intervention)
- Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits(At 10 weeks after start of intervention)
- Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits(At 10 weeks after start of intervention)
- Psychological Stress Assessed by the Perceived Stress Scale (PSS)(At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention)
- Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory(At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention)
- Minutes of Home Practice Completed(Up 10 weeks after start of intervention)
- Percent of Planned In Person Intervention Sessions Attended(At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention)
- Number of Participants With Successful Qualitative Data Collection(At 14 weeks after start of intervention)
- Circadian Disruption (Daily)(At 0-2 weeks after start of intervention)
- Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits(At 2 weeks after start of intervention)
- Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits(At 2 weeks after start of intervention)
- Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits(At 2 weeks after start of intervention)