Walking for Recovery From Surgery: Pilot Study of a Prehabilitation Intervention for Older Adults With Cancer and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Pedometer-assessed daily steps (patients)
研究概览
简要总结
This pilot clinical trial studies how well Walking for Recovery from Surgery works in improving quality of life in older adults with lung or gastrointestinal cancer and their family caregivers. A walking program, such as Walking for Recovery from Surgery may help support overall well-being as a caregiver, and may help improve family member or friend's recovery from surgery.
详细描述
PRIMARY OBJECTIVES:
I. To examine whether the intervention and telehealth approach would be feasible and acceptable.
SECONDARY OBJECTIVES:
I. To examine patient outcome patterns suggesting the potential efficacy of the intervention on self-efficacy, functional status (daily steps, 6-minute walk time, timed up and go), psychological distress, symptoms, and global health status.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT: Diagnosis of lung or GI (colorectal, pancreas, liver) cancers
- •PATIENT: Scheduled to undergo surgery
- •PATIENT: >= 65 years
- •PATIENT: Able to read and understand English
- •CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery
- •CAREGIVER: >= 21 years
- •CAREGIVER: Able to read and understand English
- •This study will be conducted in patients and family caregivers who are scheduled to undergo lung or GI cancer surgery treatment
- •There are no restrictions related to performance status or life expectancy
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
排除标准
- 未提供
结局指标
主要结局
Pedometer-assessed daily steps (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Timed-up and go (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Self-efficacy (caregivers)
时间窗: Up to 2 months
Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy-Short Form. Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Distress assessed using Distress thermometer (caregivers)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Functional status (caregivers)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Symptoms (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
6-minute walking time (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Short Physical Performance Battery (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Geriatric assessment
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
Distress level assessed using Distress Thermometer (patients)
时间窗: Up to 2 months
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
次要结局
未报告次要终点