Study of Stress Management and Exercise Intervention During Cancer Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Medical Outcomes Survey-Short Form (SF-36, acute)
研究概览
简要总结
Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients.
This study seeks to evaluate the separate and combined effects of stress management training and exercise training on quality of life during chemotherapy treatment. Participants receive either a home-based, self-administered program in 1 of 3 types (stress management, exercise, or stress management + exercise) or usual care (reading materials). It is hypothesized that the combined program (stress management + exercise) will be significantly associated with better quality of life than the usual care group, the exercise only group, and the stress management only group. All participants are assessed at 3 timepoints: before they begin chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first infusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants must:
- •Be diagnosed with cancer
- •Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks
- •Be ≥18 years of age or older
- •Have an ECOG performance status of 0, 1, or 2
- •Be capable of speaking and reading English
- •Be able to provide informed consent
排除标准
- •ECOG of 3 or greater
- •Presence of contraindications to participating in moderate intensity exercise including:
- •. metastases to weight-bearing sites (spine, pelvis, lower extremities)
- •. active infections
- •. cardiomyopathy or congestive heart failure
- •. severe pulmonary or ventilatory disease (FEV 1.0<50%)
- •. large pleural effusions or pericardial effusions
- •. anemia (Hgb <8g/dL)
- •. neutropenia (absolute neutrophil count < 0.05 x 10(9th)/L)
- •. severe osteoporosis (> 2.5 SD below age and gender norms)
- •. thrombocytopenia (platelets < 20 x 10(9th)/L)
- •. hyponatremia (Na+ < 130 mmol/L)
- •. hypokalemia (K+ ≤ 3.0 mmol/L)
- •. hypercalcemia (Ca++ > 6.5 mmol/L)
- •. abnormal ECG
- •. sensorimotor deficits sufficient to impede unassisted walking
- •Receipt of intravenous chemotherapy administration in the past 2 months
- •Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications
- •Presence of other contraindications as determined by the attending oncologist and research staff
研究组 & 干预措施
1
Active Control: Usual Care
干预措施: Usual care (Behavioral)
2
Stress Management Intervention
干预措施: Stress Management training (Behavioral)
3
Exercise Intervention
干预措施: Exercise Training (Behavioral)
4
Combined Stress Management and Exercise Intervention
干预措施: Combined stress management and exercise training (Behavioral)
结局指标
主要结局
Medical Outcomes Survey-Short Form (SF-36, acute)
时间窗: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion
次要结局
- Center for Epidemiological Studies-Depression (CES-D)(pre-chemotherapy baseline, 6- & 12- weeks post-baseline)
- Beck Anxiety Inventory (BAI)(pre-chemotherapy baseline, 6- & 12-weeks post-baseline)