Prehabilitation in Patients With Esophageal or Gastric Cancers

Gastric Cancer Clinical Trial

Official title:

Prehabilitation in Patients With Esophageal or Gastric Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418298
• Other study ID #: e-move
• Status: Completed
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: May 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 15, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer
• Stomach Neoplasms

Intervention

Behavioral:
• Prehabilitation group
Subjects will performed an internet-based exercise program before surgery

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Woluwé-Saint-Lambert

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	Proportion of patients who complete the tele-prehabilitation and all assessments	At study completion (3 months after surgery)
Primary	Attendance	(Number of completed sessions/Number of planned sessions) x 100	At study completion (3 months after surgery)
Primary	Program satisfaction	Program satisfaction will be evaluated by a questionnaire including items about internet program	At study completion (3 months after surgery)
Primary	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)
Primary	Recruitment rate	ratio of the number of the recruited patients to the number of eligible patients	At study completion (3 months after surgery)
Secondary	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
Secondary	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
Secondary	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
Secondary	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