Esophageal Cancer Multimodal Prehabilitation Study
- Conditions
- Esophageal CancerEsophageal Neoplasms
- Interventions
- Behavioral: Prehabilitation Program
- Registration Number
- NCT06027515
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prehabilitation Program Prehabilitation Program 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.
- Primary Outcome Measures
Name Time Method Enrollment Rate (Feasibility) At screening Number of eligible patients who enroll in study
Completion Rate (Feasibility) 30 days Defined as the number of patients who complete study procedures.
- Secondary Outcome Measures
Name Time Method Sleep Health Compliance Rate (Feasibility) 30 days 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.
Nutrition Compliance Rate (Feasibility) 5 days 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.
Physical Function Compliance Rate (Feasibility) 30 days 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.
Actigraphy Compliance Rate (Feasibility) 30 days Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States