NCT00460668

Brief Summary

The purpose of this study is to evaluate the effects of an integrated multidisciplinary rehabilitation program on health related quality of life in the 12 months postoperative period in patients with an elective thoracotomy and to evaluate the effects of the program on general quality of life (SF-36), acute/chronic post-thoracotomy pain, impairment (changes in pulmonary function), disability (exercise capacity) and start to complete recovery (ECOG score of 0 or 1) 12 months postoperatively in patients with an elective thoracotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

3.4 years

First QC Date

April 13, 2007

Last Update Submit

April 5, 2013

Conditions

Lung CancerThoracotomyPulmonary Rehabilitation

Keywords

elective thoracotomypulmonary rehabilitationquality of life

Outcome Measures

Primary Outcomes (1)

  • SGRQ total score

    12 months

Secondary Outcomes (3)

  • SF-36 scores

    12 months

  • McGill pain questionnaire scores

    12 months

  • Pulmonary function and 6MWD

    3 months

Study Arms (2)

Pulmonary rehabilitation post-thoracotomy

EXPERIMENTAL

Pulmonary rehabilitation post-thoracotomy

Behavioral: pulmonary rehabilitation

Control

NO INTERVENTION

Control

Interventions

pulmonary rehabilitationBEHAVIORAL

2 or 3 times a week during 8 weeks

Pulmonary rehabilitation post-thoracotomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective, thoracotomy patients with a surgical intention to cure.
  • age between 18 and 80 years.
  • ECOG 0 - 2 post-thoracotomy.

You may not qualify if:

  • patients with chronic pain.
  • a previous thoracotomy.
  • comorbidity limiting rehabilitation.
  • non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • J.A. Stigt

    Isala

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 16, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

NL(1)