The Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life
Condition: Lung Cancer; Thoracotomy; Pulmonary Rehabilitation
Study type: Interventional

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.
    

Detailed description: 
      Morbidity in the post operative phase of thoracotomies is characterised by pain, dyspnea,
      shoulder dysfunction and a loss of exercise tolerance may occur. There is literature about
      post-thoracotomy painsyndromes and postoperative quality of life has been investigated.
      However, data on post-thoracotomy rehabilitation and influence on morbidity and recovery are
      not available.

      Aim of the study:

      Primary: 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.

      Secondary: 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.

      Study design: prospective single-centre, open randomised trial. Eighty-eight elective
      thoracotomy patients with an age between the 18 and 80 years will be recruited during two
      years. The follow up for each patient will be one year. The exclusion criteria are chronic
      pain involvement, a previous thoracotomy, comorbidity limiting rehabilitation, psychiatric
      illness and non- compliance.

      Patients will be asked for participation before thoracotomy by informed consent and will be
      randomised post-thoracotomy, before discharge into a rehabilitation or 'regular care' group.
      Randomisation will take place for rehabilitation or regular care by a minimisation program
      with special attendance to age (< 70 or ≥ 70 years), gender, the result of the 6 minute walk
      test (< 100 m or ≥ 100 m), the FEV (FEV1< 40% or ≥ FEV1 40 %) and type of surgery
      (pneumectomy vs other). During screening a spirometry and a 6 minute walk test will be
      performed. The first questionnaires (VAS, McGill pain questionnaire) will be given to the
      patients after enrolment and before thoracotomy. The post-thoracotomy pain management
      consists of the standard analgetic treatment; a thoracic epidural catheter which will be
      slowly replaced by paracetamol, opioids and NSAID's. The consumption of analgetics will also
      be documented in the follow up. Supplementary oxygen and lung inhalation is given when
      necessary. This will be scored too. Regular physical therapy will be started directly after
      thoracotomy as soon as possible.

      The rehabilitation program will be initiated within a month after discharge. The degree of
      the rehabilitation program will be separately detected for each patient by a cycle test
      (heart rate) within 3 weeks post-thoracotomy. Patients in the pulmonary rehabilitation
      program will be guided by a multidisciplinary team of pulmonologist, physical therapist and
      social worker during 12 weeks. The program will last 3 x 2 hours weekly consisting of
      exercise training and education.

      All patients will be followed up after discharge at 1 month, 3 months, 6 months and 12 months
      at the outpatient clinic of the pulmonology department and the pain clinic of the anaesthesia
      department. Before discharge and at these intervals (except for the SGRQ at 1 month),
      patients have to fill questionnaires about quality of life (SF-36 and SGRQ) and pain (McGill
      pain questionnaire and VAS). Exercise capacity by means of the 6 minutes walk test and
      spirometry will be measured after the accomplishment of the rehabilitation program at 3
      months.

      During follow up all the results between the experimental rehabilitation group and the
      regular care group will be compared. In the interpretation of these results start to complete
      recovery is defined as ECOG 0 and 1.

      Randomisation, blinding and treatment allocation Randomisation will take place for
      rehabilitation or regular care by a minimisation program with special attendance to age (< 70
      or ≥ 70 years), gender, the result of the 6 minute walk test (< 100 m or ≥ 100 m), the FEV1
      (FEV1< 40% or ≥ FEV1 40 %), and type of surgery (pneumectomy vs other).

      Study population:

      Eighty-eight patients with an elective thoracotomy between the age of 18 and 80 years.

      Intervention:

      An early pulmonary rehabilitation program during 12 weeks initiated after discharge from the
      hospital.

      Inclusion criteria:

        1. elective, thoracotomy patients with a surgical intention to cure.

        2. age between 18 and 80 years.

        3. ECOG 0 - 2 post-thoracotomy.

      Exclusion criteria:

        1. patients with chronic pain.

        2. a previous thoracotomy.

        3. comorbidity limiting rehabilitation.

        4. non-compliance.

      Main study endpoints

      1. health related quality of life (SGRQ score). Secondary study endpoints

        1. general quality of life (SF-36).

        2. acute / chronic post-thoracotomy pain (McGill and VAS).

        3. impairment (changes in pulmonary function).

        4. disability (exercise capacity; 6 Minute Walking Distance).

        5. start to complete recovery (ECOG score of 0 or 1).

      Statistical analysis: All analysis will be on an intention-to-treat basis. The primary
      analysis will be on an intention-to-treat basis. The mean change in the primary endpoint
      (SGRQ total score) after 6 months between the groups will be analysed using unpaired t-tests.
      These tests will also be used to analyse differences after 12 months in secondary endpoints
      (SF-36 scores, 6-minute walking difference, pain scores, and lung function values). Since
      some study endpoints (quality of life and pain scores) will be measured more than two times
      (repeatedly measured) the course of these scores in time will be tested using
      MANOVA-analysis. To test for differences in proportions (proportion of patients with an
      ECOG-score of 0 or 1 after rehabilitation) the Chi2 -test will be used.

      Burden and risks associated with participation:

      There are no adverse effects due to the rehabilitation program. Patients in the 'regular
      care' group will not be guided by the multidisciplinary rehabilitation team. The
      disadvantages are the following: Patients have to fill in quality of life questionnaires,
      pain questionnaires and have to evaluate painscales (SGRQ, SF-36; McGill Pain questionnaire
      and VAS) have to perform the 6 minutes walk-test and a spirometry twice. Finally, patients
      have to visit the pulmonologist and the pain clinic more frequently. The expected benefits
      are a better exercise tolerance, less pain and a better quality of life; a faster recovery.
    

Intervention name(s): pulmonary rehabilitation
Intervention type(s): Behavioral
Intervention description(s): 2 or 3 times a week during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: elective thoracotomy; pulmonary rehabilitation; quality of life