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Behavioral Intervention

Prehabilitation Program for Esophageal Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I have finished treatment before surgery for esophageal cancer.

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My esophageal cancer surgery is scheduled in at least 4 weeks.

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I am 65 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Completion Rate (Feasibility)

Enrollment Rate (Feasibility)

Secondary outcome measures

Actigraphy Compliance Rate (Feasibility)

Nutrition Compliance Rate (Feasibility)

Physical Function Compliance Rate (Feasibility)

+1 more

Other outcome measures

6-Minute Walk Test

BMI

Energy expenditure

+5 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,934 Previous Clinical Trials

13,198,551 Total Patients Enrolled

Hassan Dashti, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment stage of this experiment accessible to participants?

"Evidently, this medical trial is not currently accepting enrolments. This research project was initially advertised on October 1st 2023 and saw its last update 6th September 2023. Despite the lack of recruitment for this clinical trial, there are 392 other trials actively recruiting patients at present."

Answered by AI

What objectives does this clinical trial intend to accomplish?

"The primary outcome of this trial, assessed at screening and completion is the Feasibility Completion Rate. To meet secondary objectives, Physical Function Compliance (measured by daily check-ins and wearable device), Sleep Health Compliance (monitored with actigraphy) and Actigraphy Compliance (with total daily hours of wear-time on a watch/wearable device) are measured against an 80% cut off to indicate compliance."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Esophageal Cancer Multimodal Prehabilitation Study

Hassan Dashti 2023. "Esophageal Cancer Multimodal Prehabilitation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027515.

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