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Completed

NCT Number: NCT03418298

Prehabilitation in Patients With Esophageal or Gastric Cancers

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Woluwé-Saint-Lambert, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation group

Behavioral

Subjects will performed an internet-based exercise program before surgery

Primary outcomes

  1. Retention rate

    Time frame: At study completion (3 months after surgery)

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

  2. Attendance

    Time frame: At study completion (3 months after surgery)

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

  3. Program satisfaction

    Time frame: At study completion (3 months after surgery)

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

  4. Percentage of patients who experienced one or more adverse events

    Time frame: 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)

  5. Recruitment rate

    Time frame: At study completion (3 months after surgery)

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

Secondary outcomes

  1. Change in functional capacity

    Time frame: Baseline, one day before surgery, 1 and 3 months after surgery

    Functional capacity will be assessed by 6-minute walk test

  2. Change in quality of life

    Time frame: 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.

  3. Change in fatigue

    Time frame: 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.

  4. Change in anxiety and depression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2018
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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