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Behavioral Intervention
Prehabilitation Program for Esophageal Cancer
Boston, MA
N/A
Recruiting
Led By Hassan Dashti, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer
At least four weeks to esophageal cancer surgery
Must not have
Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.
Women who are pregnant, nursing, or at risk of becoming pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial studies if pre-surgery health program can help older people with esophageal cancer prepare for surgery.
Who is the study for?
This trial is for English-speaking adults aged 65 and over with esophageal cancer, who have completed neoadjuvant therapy and are awaiting surgery. They must be able to participate in physical activities and not have skin issues that interfere with sensor use. Pregnant women or those in other studies are excluded.
What is being tested?
The study tests a prehabilitation program designed to boost patients' fitness, nutrition, and sleep before their esophageal cancer surgery. It aims to see if this approach is practical for older patients at higher risk due to their condition.
What are the potential side effects?
Since the intervention involves non-medical procedures like exercise, nutritional guidance, and sleep improvement strategies, side effects may include muscle soreness from physical activity or potential dietary changes but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have finished treatment before surgery for esophageal cancer.
Select...
My esophageal cancer surgery is scheduled in at least 4 weeks.
Select...
I am 65 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe physical disability that prevents me from doing any form of exercise.
Select...
I am not pregnant, nursing, or at risk of becoming pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completion Rate (Feasibility)
Enrollment Rate (Feasibility)
Secondary study objectives
Actigraphy Compliance Rate (Feasibility)
Nutrition Compliance Rate (Feasibility)
Physical Function Compliance Rate (Feasibility)
+1 moreOther study objectives
6-Minute Walk Test
BMI
Energy expenditure
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prehabilitation ProgramExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prehabilitation Program
2018
Completed Early Phase 1
~100
Find a Location
Closest Location:Massachusetts General Hospital· Boston, MA
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,759 Total Patients Enrolled
Hassan Dashti, PhDPrincipal InvestigatorMassachusetts General Hospital