Rehabilitation by Effort for Patients With Advanced Bronchial Cancer (RehabKBP)
Primary Purpose
Bronchial Cancer, Malignant Mesothelioma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rehabilitation by effort
Sponsored by
About this trial
This is an interventional supportive care trial for Bronchial Cancer focused on measuring bronchial cancer, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- General condition according to World Health Organisation 0-1
- Age between 18 and 70 years old
- Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment
- Autonomous patient
- Voluntary written informed consent signed
- Patients with social security insurance
Exclusion Criteria:
- Bone metastasis with fracture risk
- Significant cardiovascular pathology
- Cardiac, vascular, rheumatologic or neurologic contraindication
- Patients living far 60 kms from Toulouse
- Patients under juridical protection guardianship, or tutelage measure
Sites / Locations
- CHU de Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rehabilitation by effort
Arm Description
8 sessions of rehabilitation by effort in sports medicine
Outcomes
Primary Outcome Measures
patients who completed at least 6 sessions of rehabilitation
number of patients who completed at least 6 sessions of rehabilitation by effort
Secondary Outcome Measures
Full Information
NCT ID
NCT03684486
First Posted
September 24, 2018
Last Updated
September 18, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03684486
Brief Title
Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
Acronym
RehabKBP
Official Title
Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
July 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life.
Investigators want to ensured the feasibility of rehabilitation by effort for these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Cancer, Malignant Mesothelioma
Keywords
bronchial cancer, rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rehabilitation by effort
Arm Type
Experimental
Arm Description
8 sessions of rehabilitation by effort in sports medicine
Intervention Type
Behavioral
Intervention Name(s)
rehabilitation by effort
Primary Outcome Measure Information:
Title
patients who completed at least 6 sessions of rehabilitation
Description
number of patients who completed at least 6 sessions of rehabilitation by effort
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General condition according to World Health Organisation 0-1
Age between 18 and 70 years old
Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment
Autonomous patient
Voluntary written informed consent signed
Patients with social security insurance
Exclusion Criteria:
Bone metastasis with fracture risk
Significant cardiovascular pathology
Cardiac, vascular, rheumatologic or neurologic contraindication
Patients living far 60 kms from Toulouse
Patients under juridical protection guardianship, or tutelage measure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Mazières, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
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