A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
概览
- 阶段
- 不适用
- 干预措施
- PREHAB
- 疾病 / 适应症
- Pancreas Cancer
- 发起方
- Cedars-Sinai Medical Center
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions.
- 状态
- 进行中（未招募）
- 最后更新
- 17天前
概览
简要总结
The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.
详细描述
Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored. Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).
研究者
Philip Chang
Sponsor-Investigator
Cedars-Sinai Medical Center
入排标准
入选标准
- •Pancreatic cancer diagnosis (any stage)
- •Age ≥ 18 years
- •Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist)
- •Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
- •Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics
- •Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist
- •Ability to read, write and understand English
- •Written informed consent obtained from subject and ability for subjects to comply with the requirements of the study
- •Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main study):
- •Access to a smart device capable of Fitbit syncing and accessing the online Pain portal (www.painguide.com)
排除标准
- •Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention
- •Current pregnancy
- •Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):
- •Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the PI deems study participation safe.
研究组 & 干预措施
Supervised Prehabilitation Exercise Program
干预措施: PREHAB
结局指标
主要结局
PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions.
时间窗: From Baseline to 3 Months
PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
PREHAB Feasibility
时间窗: From Baseline to 3 Months
PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions. PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
次要结局
- PREHAB Program safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.(From Baseline to 3 Months)
- PREHAB Program Safety(From Baseline to 3 Months)