Esophageal Cancer Multimodal Prehabilitation Study

Study Overview
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Brief Summary
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The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.

Detailed Description
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This research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer. Research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and Computed Tomography (CT) scans. Participation in this research study is expected to last 7 months. It is expected about 30 patients will participate in this study.

Official Title
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A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery

Conditions
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Esophageal Cancer, Esophageal Neoplasms

Intervention / Treatment
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* Behavioral: Prehabilitation Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years of age and over Adult male or non-pregnant female volunteers Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer At least four weeks to esophageal cancer surgery Without skin conditions that preclude wearing sensors Able to speak English and consent Exclusion Criteria: Participants in any other interventional study that may bias results or limit study adherence during our study Dietary restrictions that prevent consumption of nutritional supplements Women who are pregnant, nursing, or at risk of becoming pregnant Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation Program<br>30 participants will be enrolled and will complete study procedures as follows: Enrollment at least 4 weeks prior to esophageal cancer surgery. In-person clinic visit with dietitian and physical therapist for assessments, and completion of baseline questionnaires with study coordinator. Adherence to daily physical function, dietary, and sleep recommendations and consumption of 5-day immunonutrition supplement. Regular electronic/phone-call check-ins with study staff. Telehealth appointment with physical therapist and dietitian prior to surgery. After surgery and during hospital admission, final visit with dietitian and physical therapist for assessments, and completion of questionnaires. 6-month follow-up period. | Behavioral: Prehabilitation Program<br>* Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate (Feasibility) | Number of eligible patients who enroll in study | At screening | 
| Completion Rate (Feasibility) | Defined as the number of patients who complete study procedures. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Compliance Rate (Feasibility) | Comparison of number of nutritional supplements consumed compared to number of nutritional supplements prescribed as determined from daily check-ins. A cut-off value of 80% will be used to indicate compliance. | 5 days | 
| Physical Function Compliance Rate (Feasibility) | Comparison of the total minutes of physical function completed compared to the total minutes of physical function prescribed as determined from daily check-ins and wearable device. A cut-off value of 80% will be used to indicate compliance. | 30 days | 
| Sleep Health Compliance Rate (Feasibility) | Comparison of the average daily hours of sleep duration, minutes of wake after sleep onset, and variability in sleep timing, achieved compared to prescribed as determined from actigraphy. A cut-off value of 80% will be used to indicate compliance. | 30 days | 
| Actigraphy Compliance Rate (Feasibility) | Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Esophageal Neoplasms