Esophageal CancerNCT03418298
Prehabilitation in Patients With Esophageal or Gastric Cancers
A study testing Prehabilitation group in people with Esophageal Cancer and Gastric Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Prehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Feb 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Surgical emergency
- Cognitive or neuropsychiatric diseases
- Neuromuscular or orthopedic disorders limiting exercises
- Cardiopulmonary disease contraindicating exercises
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Woluwé-Saint-Lambert, 1200
About this study
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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Prehabilitation group
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation groupBehavioural
Subjects will performed an internet-based exercise program before surgery
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | Subjects will carry out a preoperative internet-based program including aerobic and resistance training three sessions per week Receives: Behavioral: Prehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Proportion of patients who complete the tele-prehabilitation and all assessments
Measured: At study completion (3 months after surgery)
Attendance
(Number of completed sessions/Number of planned sessions) x 100
Measured: At study completion (3 months after surgery)
Program satisfaction
Program satisfaction will be evaluated by a questionnaire including items about internet program
Measured: At study completion (3 months after surgery)
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)
Measured: At study completion (3 months after surgery)
Recruitment rate
ratio of the number of the recruited patients to the number of eligible patients
Measured: At study completion (3 months after surgery)
Secondary outcomes (4)
Change in functional capacity
Functional capacity will be assessed by 6-minute walk test
Measured: Baseline, one day before surgery, 1 and 3 months after surgery
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.
Measured: Baseline, one day before surgery, 1 and 3 months after surgery
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.
Measured: Baseline, one day before surgery, 1 and 3 months after surgery
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
Measured: Baseline, one day before surgery, 1 and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start27 Feb 2018
- Primary completion1 Nov 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418298
- Sponsor's protocol ID
- e-move
- Status last verified
- May 2020
- First submitted
- 10 Jan 2018
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation in Patients With Esophageal or Gastric Cancers
- ClinicalTrials.gov ID
- NCT03418298
- Acronym / sponsor ID
- e-move
- Conditions
- Esophageal Cancer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Prehabilitation groupSubjects will carry out a preoperative internet-based program including aerobic and resistance training three sessions per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Surgical emergency
- Cognitive or neuropsychiatric diseases
- Neuromuscular or orthopedic disorders limiting exercises
- Cardiopulmonary disease contraindicating exercises
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation groupSubjects will performed an internet-based exercise program before surgery | Behavioural | Prehabilitation group |
Primary outcome
Retention rate
Time frame: At study completion (3 months after surgery)
Proportion of patients who complete the tele-prehabilitation and all assessments
Attendance
Time frame: At study completion (3 months after surgery)
(Number of completed sessions/Number of planned sessions) x 100
Program satisfaction
Time frame: 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
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)
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
4 secondary outcomes
Change in functional capacity
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Change in quality of life
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Change in fatigue
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Change in anxiety and depression
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation group in people with Esophageal Cancer and Gastric Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: At study completion (3 months after surgery)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.