Pilot Study of a Progressive Exercise Program Among Lung Cancer Patient-Partner Dyads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Study Feasibility: Proportion enrolled
研究概览
简要总结
Pilot study of an exercise program among patients with all stages of lung cancer examining feasibility and acceptability. Preliminary outcomes include objective measures of physical function, depression, adherence to lung cancer treatments, Quality of Life (QOL), and social support.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility and acceptability of a progressive exercise program initiated after lung cancer diagnosis among patient partner dyads.
SECONDARY OBJECTIVE:
I. Examine the preliminary effects of partnered exercise on physical function, depression, adherence to lung cancer treatments, QOL and social support .
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild depression symptoms
- •Able to participate in exercise program per physician approval
- •Available partner/spouse to participate with patient
排除标准
- •Persistent severe depression symptoms
- •Inability to participate in exercise
- •Life expectancy less than 1 year
研究组 & 干预措施
Supportive care (exercise)
Participants attend supervised group exercises classes twice per week during weeks 1-6 and once per week during weeks 7-12. Participants also attend home-based unsupervised exercise sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and twice per week during weeks 7-12.
干预措施: Exercise Intervention (Behavioral)
Supportive care (exercise)
Participants attend supervised group exercises classes twice per week during weeks 1-6 and once per week during weeks 7-12. Participants also attend home-based unsupervised exercise sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and twice per week during weeks 7-12.
干预措施: Survey Administration (Other)
Supportive care (exercise)
Participants attend supervised group exercises classes twice per week during weeks 1-6 and once per week during weeks 7-12. Participants also attend home-based unsupervised exercise sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and twice per week during weeks 7-12.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Study Feasibility: Proportion enrolled
时间窗: 12 weeks
Will be measured as the number of couples who enroll out of those approached. Will evaluate using descriptive statistics.
Study Acceptability: Average attendance
时间窗: 12 weeks
Will be measured by the average attendance at sessions over the course of the intervention. This will be calculated as the total number of classes attended divided by the total possible they could have attended over the course of the study. Attendance will be categorized by sessions couples attended together and those where only one partner attends. Will evaluate using descriptive statistics.
次要结局
- Change in physical function over time: 6-minute walk(12 weeks)
- Incidence of Relationship Strain(12 weeks)
- Level of exercise outside the exercise intervention assessed by GLTEQ(12 weeks)
- Subjective evaluation of PEP-LC participant experience from phone interviews(1-2 months follow completion of program (up to 4 months))
- Change in physical function over time: Hand grip test(12 weeks)
- Change in physical function over time: Short Physical Performance Battery(12 weeks)
- Fatigue assessed by PROMIS Short-Form(12 weeks)
- Incidence of Depression(12 weeks)
- Relationship Distress assessed by DAS-SF(12 weeks)
- Incidence of Malnutrition(12 weeks)
- Quality of Life for participants with lung cancer assessed by FACT-L(12 weeks)
- Quality of Life for exercise partners assessed by CQOLC(12 weeks)
- Pain assessed by PROMIS Short-Form(12 weeks)
- Sleep assessed by PROMIS Short-Form(12 weeks)
- Social Support assessed by PSSS(12 weeks)
研究者
Donald Sullivan
Assistant Professor
OHSU Knight Cancer Institute