PrehabPal: A Digital Tool to Help Frail Elders Prepare for Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- Proportion of days before surgery engaged in prehabilitation
研究概览
简要总结
This is a multi-center, randomized trial investigating the use of PrehabPal web app versus a written surgery prehabilitation instructions among individuals aged 65 years and older preparing for colon cancer surgery. PrehabPal is a web app designed with, and for, older adults preparing for surgery at University of California, San Francisco (UCSF). This app has the potential to fill a crucial clinical gap for older cancer patients by designing an individualized prehabilitation program and providing prehabilitation coaching.
详细描述
PRIMARY OBJECTIVE:
I. Determine the effectiveness of PrehabPal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery.
SECONDARY OBJECTIVES:
I. Determine the impact of PrehabPal on surgical outcomes and functional recovery compared to standard written surgery prehabilitation materials.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >=65 years of age at time of evaluation for colorectal cancer resection.
- •Documentation of a colorectal diagnosis as evidenced by the following criteria:
- •a. Biopsy proven colorectal cancer or unresectable neoplastic polyp.
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- •Self-reported access to the Internet.
- •Participant has at least seven days prior to surgery date to optimize for surgery.
- •English language proficient.
排除标准
- •No English language proficiency.
- •No Internet access.
- •Documented diagnosis of dementia or Alzheimer's disease.
- •Surgery scheduled within 7-days.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
研究组 & 干预措施
PrehabPal Web app
Web app based initial geriatric assessment will be given followed by daily tailored prehabilitation activities in the domains of exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. Each participant is paired with a central health coach who monitors engagement and provides support through the Web app portal.
干预措施: PrehabPal (Behavioral)
Written Surgery Prehabilitation Instructions
Participants will be provided paper-based prehabilitation instructions that include information about exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. A paper diary is provided to record any prehabilitation activities.
结局指标
主要结局
Proportion of days before surgery engaged in prehabilitation
时间窗: Up to 14 days
The proportion of days before surgery engaged in prehabilitation between subjects randomized to the PrehabPal Web App and written prehabilitation materials using logistic regression. Since sites may not balance, all relevant sociodemographic and clinical characteristics of the subjects may be included in the models which will include other factors that are not balanced between the sites.
次要结局
- Proportion of participants with reported Surgical Complications(30 days following surgery)
- Readmission Rate(30 days following surgery)
- Change in Mean score on the SF-36(Up to 8 weeks)
- Median Length of Stay (LOS)(Post procedure until discharge, approximately 2 days)