Prehabilitation in Patients With Esophageal or Gastric Cancers

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Completed

CT.gov ID

NCT03418298

Collaborator

(none)

Enrollment

Location

Arm

21.6

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Behavioral: Prehabilitation group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prehabilitation in Patients With Esophageal or Gastric Cancers

Actual Study Start Date :

Feb 27, 2018

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Dec 15, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Prehabilitation group

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

Behavioral: Prehabilitation group

Subjects will performed an internet-based exercise program before surgery

Outcome Measures

Primary Outcome Measures

Retention rate [At study completion (3 months after surgery)]
Proportion of patients who complete the tele-prehabilitation and all assessments
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
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

Secondary Outcome Measures

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
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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels	Woluwé-Saint-Lambert	Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT03418298

Other Study ID Numbers:

e-move

First Posted:

Feb 1, 2018

Last Update Posted:

May 21, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of May 21, 2020