Prehabilitation in Patients With Esophageal or Gastric Cancers

Study Overview
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Brief Summary
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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.

Official Title
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Prehabilitation in Patients With Esophageal or Gastric Cancers

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Behavioral: Prehabilitation group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |