Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal…
ID
Bron
Verkorte titel
Aandoening
lung cancer, post operative pain, VATS, RATS, longkanker
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the effects of an integrated multidisciplinary rehabilitation program on general quality of life (short form 36, SF-36, subdomain general health) in the 12 months postoperative period in patients undergoing elective minimal invasive surgery in lung cancer.
Achtergrond van het onderzoek
Rationale: Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain (1). Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.
Objective: To evaluate the effect of integrated multidisciplinary rehabilitation on quality of life (QOL) in the 12 months postoperative phase in patients with lung cancer undergoing minimal invasive surgery.
Study design: The study conducted will be a prospective randomised controlled trial, between multidisciplinary rehabilitation and standard care.
Study population: All patients between 18 and 80 with lung cancer undergoing minimal invasive surgery (video-assisted or robot assisted thoracoscopic surgery).
Intervention (if applicable): The intervention group will have an integrated multidisciplinary rehabilitation program consisting of an extensive physical training program for 3 months, visits to the pain clinic, visits to the social worker and, if indicated to the psychologist.
Main study parameters/endpoints: Effects on quality of life will be our main endpoint. T this will be tested with the following questionnaires: short form health survey (SF-36), St. George Respiratory questionnaire (SGRQ) and the World Health Organization Performance Score (WHO-PS). Furthermore, pain scores will be monitored with the visual analogue scale (VAS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Our intervention group will follow a physical training programme for 3 months. In these three months our patients will be invited to train two times a week in the hospital under supervision of oncologic qualified physical therapists. The intervention group will have at least one scheduled visit to the pain clinic. If necessary further visits to the pain clinic will be scheduled. All patients will visit the social worker and a psychologist if indicated. Both intervention and standard care groups will receive questionnaires at prespecified times. The physiological and physical burden associated with our study will be guarded by a trial nurse who will frequently contact the patients.
Doel van het onderzoek
Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.
Our main goal is to evaluate the effects of an integrated multidisciplinary rehabilitation program on general quality of life (short form 36, SF-36, subdomain general health) in the 12 months postoperative period in patients undergoing elective minimal invasive surgery in lung cancer.
Onderzoeksopzet
After inclusion patients will follow a prespecified rehabilitation course, tests and questionaires will be conducted during one year follow up after surgery.
Onderzoeksproduct en/of interventie
multidisciplinary rehabilitation
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients undergoing minimal invasive surgery for lung cancer, ages between 18 and 80 years.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Patients undergoing elective, minimal invasive surgery with intention to cure.
2. Age between 18 and 80 years.
3. ECOG 0 – 2 post-surgery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients with chronic pain
2. Previous pulmonary surgery
3. Comorbidity limiting rehabilitation
a. Rheumatoid arthritis
b. Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
c. Muscle disease
d. Fibromyalgia
e. Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
f. Psychiatric disorders
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6386 |
NTR-old | NTR7658 |
Ander register | : ABR 63724 |