Impact of Pulmonary Rehabilitation After Lung Resection f... | NCT04985474

Studies
Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression

NCT04985474

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Aug 2, 2021Actual

Enrollment

133Actual

Phase

Not provided

Conditions

Pulmonary Resection

Interventions

questionnaires

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 13, 2016

First Submission Date that Met QC Criteria

Jul 21, 2021

First Posted Date

Aug 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2021

Last Update Posted Date

Aug 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The interest of pulmonary rehabilitation for patients who underwent lung resection for cancer remains controversial. The investigators studied the effects of the RR and its impact on quality of life and level of anxiety and depression in patients.

In 2011 and 2012 , an RR was proposed to the patients referred to our center after lung resection for cancer. Patients were assessed at entry and departure by 6minutes walk test , a visual analog pain scale , a quality of life questionnaire ( EORTC QLQ C30 ) and an anxiety questionnaire and Depression (HAD) . These same questionnaires were mailed 6 months after the end of the pulmonary rehabilitation .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

133Actual

Label	Type	Description	Intervention Names
Pulmonary resection			Other: questionnaires

Name	Type	Description	Arm Group Labels	Other Names
questionnaires	Other		Pulmonary resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
level of depression with scale	Assess the level of depression during and after a respiratory rehabilitation training in institutions	At 6 months
level of anxiety withe scale	Assess the level of anxiety during and after a respiratory rehabilitation training in institutions	At 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with pulmonary resection
Patients undergoing a standardized approach (or thoratomie videothoracoscopy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing a standardized approach (or thoratomie videothoracoscopy)

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

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