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| Name | Class |
|---|---|
| Pancreatic Cancer Alliance | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Prehabilitation Program | Experimental | Participants in this single-arm study will receive a structured prehabilitation program during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Prehabilitation | Behavioral | Participants will receive a structured, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. The program integrates supervised, individualized exercise training, nutritional assessment and counseling with recommended preoperative immunonutrition, and supportive care focused on symptom management and functional support. Prehabilitation is delivered as an integrated component of preoperative care and continues through completion of neoadjuvant therapy until surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of prehabilitation program delivery | Feasibility will be assessed by the proportion of enrolled participants who initiate and complete the prehabilitation program during neoadjuvant chemotherapy prior to surgery. | From enrollment through completion of neoadjuvant therapy (approximately 3-6 months) |
| Adherence to prehabilitation components | Adherence will be measured by participant-reported completion of prescribed exercise sessions and reported completion of recommended preoperative immunonutrition. | From enrollment through preoperative assessment (approximately 3-6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walk distance | Assessed using American Thoracic Society guidelines, change by difference in meters of walking distance achieved. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla R Widdowson, MD | Contact | 774-641-1257 | kayla.widdowson@umassmed.edu | |
| James M Lindberg, MD | Contact | 508-334-5220 | james.lindberg@umassmemorial.org |
| Name | Affiliation | Role |
|---|---|---|
| James M Lindberg, MD | UMass Memorial Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center | Recruiting | Worester | Massachusetts | 01655 | United States |
This is a pilot feasibility study, and no final determination has been made regarding sharing individual participant data. Decisions regarding data sharing will be informed by the size of the final dataset, privacy considerations, and the design of future confirmatory studies.
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| ID | Term |
|---|---|
| C535836 | Pancreatic cancer, adult |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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The Fried Frailty Phenotype is a five-component measure used to classify frailty status. Patients are evaluated for unintentional weight loss, weakness, slowness, poor endurance, and low physical activity (each criteria are assigned one point). A score of 0 is considered "not-frail," and a score of 1 or 2 is considered "prefrail" or at risk of frailty. A score of 3 or more meets the diagnosis of frail. The maximum possible score is 5 and higher scores indicate more frail. |
| Enrollment to preoperative assessment (up to 6 months after enrollment) |
| Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA) | The PG-SGA SF consists of four boxes: box 1, questions regarding body weight (scored 0-5); box 2, food intake (score 0-4); box 3, symptoms affecting oral food intake (scored 0-23); and box 4, regarding activities and function (score 0-4). The sum of these four boxes can range from 0 to 36 points, with the higher the score, the greater the nutritional risk. | Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment) |
| Change in body mass index (BMI) | Height in meters and weight in kilograms will be used to calculate BMI (kg/m^2). | 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 | 10-item questionnaire assessing current self-reported physical function. Raw scores are translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean. A higher T-score represents better physical function. | 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 | FACT-Hep is a a 45-item self-report instrument designed to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers. Scores range from 0-180 where higher scores indicate greater quality of life. | Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment) |
| Postoperative complications measured using Clavien-Dindo classification | Clavien-Dindo classification is a standardized system used to grade postoperative complications based on the type of intervention required to manage the complication, rather than on the complication itself. Scores range from zero to five with higher scores indicating more severe. Highest severity complication according to Clavien-Dindo classification will be recorded. | Up to 30 days after surgery (up to 1 year after enrollment) |
| Postoperative hospital length of stay | Days from surgery to discharge will be recorded | Up to 90 days postoperative (up to 14 months after enrollment) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |