Esophageal Cancer, Gastric Cancer
Conditions
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.
Interventions
BEHAVIORALPrehabilitation group
Subjects will performed an internet-based exercise program before surgery
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | At study completion (3 months after surgery) | ratio of the number of the recruited patients to the number of eligible patients |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Belgium
Outcome results
None listed