Prehabilitation in Patients With Esophageal or Gastric Cancers

NCT03418298 | Completed

• 1 other identifier: e-move
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Change in functional capacity

  Baseline, one day before surgery, 1 and 3 months after surgery

• Change in quality of life

  Baseline, one day before surgery, 1 and 3 months after surgery

• Change in fatigue

  Baseline, one day before surgery, 1 and 3 months after surgery

• Change in anxiety and depression

  Baseline, one day before surgery, 1 and 3 months after surgery

Study Arms (1)

Prehabilitation group

EXPERIMENTAL

Subjects will carry out a preoperative internet-based program including aerobic and resistance training three sessions per week

Behavioral: Prehabilitation group

Interventions

Prehabilitation group BEHAVIORAL

Subjects will performed an internet-based exercise program before surgery

Prehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Woluwé-Saint-Lambert, 1200, Belgium

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 1, 2018
• Study Start: February 27, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 15, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

BE (1)