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Prehabilitation in Patients With Esophageal or Gastric Cancers

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Prehabilitation group

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation group

Arm Description

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

Outcomes

Primary Outcome Measures

Retention rate

Proportion of patients who complete the tele-prehabilitation and all assessments

Attendance

(Number of completed sessions/Number of planned sessions) x 100

Program satisfaction

Program satisfaction will be evaluated by a questionnaire including items about internet program

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)

Recruitment rate

ratio of the number of the recruited patients to the number of eligible patients

Secondary Outcome Measures

Change in functional capacity

Functional capacity will be assessed by 6-minute walk test

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.

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.

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

Full Information

NCT ID

NCT03418298

First Posted

January 10, 2018

Last Updated

May 19, 2020

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03418298

Brief Title

Prehabilitation in Patients With Esophageal or Gastric Cancers

Official Title

Prehabilitation in Patients With Esophageal or Gastric Cancers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

November 1, 2019 (Actual)

Study Completion Date

December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prehabilitation group

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Prehabilitation group

Intervention Description

Subjects will performed an internet-based exercise program before surgery

Primary Outcome Measure Information:

Title

Retention rate

Description

Proportion of patients who complete the tele-prehabilitation and all assessments

Time Frame