Prehabilitation in Patients With Esophageal or Gastric Cancers

Objectives: The primary objective of this study is to assess the feasibility of a internet-based preoperative exercise program in patients with esophageal or gastric cancers. Secondary objectives are to evaluate the effects of this preoperative program on functional capacity, anxiety and depression, quality of life and fatigue Methods: This feasibility study will be conduct at University Hospital Saint-Luc in Brussels. Twenty patients with esophageal or gastric cancers will participate in internet-based program 3 sessions per week. Each session will combine aerobic and resistance training. Moreover, inspiratory muscle strengthening (IMT) will be performed daily. The researcher will conduct weekly telephone calls to educate and motivate subjects. Assessments will be performed at baseline, one day before surgery, 1 month and 3 months after surgery. The following parameters will be measured: functional capacity, quality of life, fatigue, anxiety and depression.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Esophageal Cancer
• Intervention / Treatment: Behavioral: Prehabilitation group

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Woluwé-Saint-Lambert
    • Brussels, Woluwé-Saint-Lambert, Belgium, 1200
      • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of esophageal cancer or gastric cancer requiring surgery
• More than 18 years
• Able to read, write and understand French or English
• Time before surgery > 2 weeks

Exclusion Criteria:

• Surgical emergency
• Cognitive or neuropsychiatric diseases
• Neuromuscular or orthopedic disorders limiting exercises
• Cardiopulmonary disease contraindicating exercises

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation group; Subjects will carry out a preoperative internet-based program including aerobic and resistance training three sessions per week	Behavioral: Prehabilitation group; Subjects will performed an internet-based exercise program before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate	Proportion of patients who complete the tele-prehabilitation and all assessments	At study completion (3 months after surgery)
Attendance	(Number of completed sessions/Number of planned sessions) x 100	At study completion (3 months after surgery)
Program satisfaction	Program satisfaction will be evaluated by a questionnaire including items about internet program	At study completion (3 months after surgery)
Percentage of patients who experienced one or more adverse events	Adverse events will be evaluated by listing adverse events that occur (e.g. fall, injury or exercise-related symptom)	At study completion (3 months after surgery)
Recruitment rate	ratio of the number of the recruited patients to the number of eligible patients	At study completion (3 months after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional capacity	Functional capacity will be assessed by 6-minute walk test	Baseline, one day before surgery, 1 and 3 months after surgery
Change in quality of life	Quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G). Each item is rated from 0 (not at all) to 4 (very much) with a total score ranging from 0 to 102. The higher the score, the better the QoL.	Baseline, one day before surgery, 1 and 3 months after surgery
Change in fatigue	Fatigue using the Functional Assessment of Cancer Therapy-Fatigue questionnaire (FACIT-F). Each item is rated from 0 (not at all) to 4 (very much) with a total score ranging from 0 to 52. The higher the score, the lower the fatigue.	Baseline, one day before surgery, 1 and 3 months after surgery
Change in anxiety and depression	Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Scores for each subscale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values, and values from 11-21 are considered to be pathological	Baseline, one day before surgery, 1 and 3 months after surgery

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: e-move

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No