Prehabilitation in Patients With Esophageal or Gastric Cancers

Not Applicable

Completed

• Conditions: Gastric Cancer; Esophageal Cancer
• Interventions: Behavioral: Prehabilitation group

• Registration Number: NCT03418298
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Study Start: 2018-02-27
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation group	Prehabilitation group	Subjects will carry out a preoperative internet-based program including aerobic and resistance training three sessions per week

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in anxiety and depression	Baseline, one day before surgery, 1 and 3 months after surgery	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
Change in quality of life	Baseline, one day before surgery, 1 and 3 months after surgery	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.
Change in fatigue	Baseline, one day before surgery, 1 and 3 months after surgery	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.
Change in functional capacity	Baseline, one day before surgery, 1 and 3 months after surgery	Functional capacity will be assessed by 6-minute walk test

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Woluwé-Saint-Lambert, Belgium