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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
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchial Cancer focused on measuring bronchial cancer, rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 24, 2018
Last Updated
September 18, 2023
Sponsor
University Hospital, Toulouse
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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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