A Phase III Randomized, Multicenter Trial Testing Whether Exercise or Stress Management Improves Functional Status and Symptoms of Autologous and Allogeneic Recipients (BMT CTN #0902)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 19
- 主要终点
- Functional Status
研究概览
简要总结
This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The purpose of this study is to test whether exercise or stress management training delivered to autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to transplantation can improve functional status and the transplant experience.
详细描述
Background:
The adverse effects of hematopoietic cell transplantation (HCT) on short and long term quality of life are well documented. Patients experience numerous aversive symptoms (e.g., nausea, fatigue, and sleep disturbance) that are accompanied by declines in physical and mental well-being. Although most longitudinal studies show return to baseline functioning for the majority of patients, it may take 6 to 12 months or longer to reach this goal. Clinical trials have shown that training in stress management techniques and participation in formal exercise programs each offered in isolation are effective in improving quality of life in patients receiving standard-dose chemotherapy and HCT. Review of these studies suggests that stress management interventions primarily improve mental health outcomes and nausea. The impact of exercise training interventions is more variable; most studies report physical health benefits, with some studies also reporting mental health benefits. Small studies suggest that combining stress management training and exercise are feasible and well-tolerated, but whether the combination provides an additive or synergistic impact on quality of life outcomes has not been directly investigated.
Design Narrative:
The protocol is designed as a factorial trial with two interventions, exercise and stress management, which results in four treatment arms: standard care, exercise only, stress management only and the combination of exercise and stress management. The primary objective of this randomized phase III trial is to test the ability of exercise training or stress management training to improve physical and mental functioning at Day 100 post hematopoietic cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Age 18 years or older
- •Able to speak and read English
- •Able to exercise at low to moderate intensity - adequate cardiopulmonary reserve, as judged by self-reported ability to walk up one flight of stairs, no requirement for supplemental oxygen, and physician judgment
- •Willing and able to provide informed consent.
- •Stated willingness to comply with study procedures and reporting requirements
- •Planned autologous or allogeneic transplantation within 6 weeks.
排除标准
- •Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence
- •Participation in another clinical trial with quality of life or functional status as a primary endpoint
研究组 & 干预措施
Exercise
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.
干预措施: Exercise (Behavioral)
Stress Management
Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.
干预措施: Stress Management (Behavioral)
Exercise and Stress Management
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.
干预措施: Exercise and Stress Management (Behavioral)
Standard Care
Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).
干预措施: Standard Care (Other)
结局指标
主要结局
Functional Status
时间窗: 100 days
To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
次要结局
- Survival(6 months and 1 year)
- SF-36 Late Outcomes(6 months)
- Cancer and Treatment Distress (CTXD)(100 days)
- The Pittsburgh Sleep Quality Index (PSQI)(100 days)
- Symptoms(100 days)
- Nausea(100 days)
- Days of Hospitalization(100 days)