Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of prehabilitation program delivery
研究概览
简要总结
The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Prehabilitation is a program designed to improve a person's physical fitness, nutrition, and symptom control before surgery.
The study's main hypothesis is that patients with pancreatic cancer can take part in and adhere to a multimodal prehabilitation program during chemotherapy, and that doing so may improve physical function, patient experience, and early recovery after surgery.
详细描述
This is a single-center, prospective pilot study designed to evaluate the implementation of a standardized, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to pancreatic cancer surgery. The intervention is integrated into routine preoperative care and includes coordinated physical activity, nutritional optimization, and supportive care components delivered throughout the neoadjuvant treatment period. Assessments are performed at baseline, after completion of the prehabilitation period and before surgery, and approximately one month after surgery to characterize participation, intervention delivery, and perioperative changes in functional and clinical measures.
Data collection includes standardized functional fitness assessments, patient-reported surveys, and abstraction of perioperative clinical data from the electronic medical record. Analyses are descriptive and exploratory, reflecting the pilot nature of the study, and are intended to characterize feasibility, adherence, and variability of measured outcomes rather than to test efficacy. Findings from this study will be used to refine intervention delivery, identify logistical and patient-level barriers, and inform the design of future larger-scale studies evaluating prehabilitation in pancreatic cancer surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- •Planned neoadjuvant chemotherapy prior to planned surgical resection
- •Medically stable and cleared to participate in physical activity/exercise programming
- •Able to provide informed consent
- •Ability to read, write and understand English
排除标准
- •Age <18 years
- •Severe cognitive impairment that precludes informed consent or participation
- •Contraindications to physical activity, including unstable cardiac disease, severe pulmonary disease, or recent myocardial infarction
研究组 & 干预措施
Multimodal Prehabilitation Program
Participants in this single-arm study will receive a structured prehabilitation program during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery.
干预措施: Multimodal Prehabilitation (Behavioral)
结局指标
主要结局
Feasibility of prehabilitation program delivery
时间窗: From enrollment through completion of neoadjuvant therapy (approximately 3-6 months)
Feasibility will be assessed by the proportion of enrolled participants who initiate and complete the prehabilitation program during neoadjuvant chemotherapy prior to surgery.
Adherence to prehabilitation components
时间窗: From enrollment through preoperative assessment (approximately 3-6 months)
Adherence will be measured by participant-reported completion of prescribed exercise sessions and reported completion of recommended preoperative immunonutrition.
次要结局
- Change in 6-minute walk distance(Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment.)
- Change in Fried Frailty phenotype between enrollment and pre-operative evaluation(Enrollment to preoperative assessment (up to 6 months after enrollment))
- Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA)(Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment))
- Change in body mass index (BMI)(Enrollment, preoperative assessment, through postoperative follow up, up to 1 year after enrollment)
- Change in physical functioning measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a(Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment))
- Change in health related quality of life measured by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score(Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment))
- Postoperative complications measured using Clavien-Dindo classification(Up to 30 days after surgery (up to 1 year after enrollment))
- Postoperative hospital length of stay(Up to 90 days postoperative (up to 14 months after enrollment))
研究者
James Lindberg
Assistant Professor
University of Massachusetts, Worcester