Clinical trial NCT01048762: Multidisciplinary Rehabilitation After Cancer Pulmonis Operation
Official title: Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Cancer
Keywords: pulmonary cancer
radically operated
exercise training
dyspnea counseling
quality of life
physical therapy
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: The Danish Cancer Foundation - Research Department - North Region
name: University of Aarhus
First posted: 2010-01-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

Detailed description: Patients who are radically operated for pulmonary cancer report suffering from respiratory problems, mostly dyspnoea, 5 years after operation. Dyspnoea restricts their physical capability and leads to poorer physical, social and mental wellbeing. The effects of training programs on physical and mental wellbeing for cancer patients are well documented. Most of the studies are though performed on patients suffering from breast, colon and prostate cancer. There are only few studies addressing patients with pulmonary cancer. They are mostly focused on short term effects of exercise training on quality of life, with no control group included in the trials. These studies target patients after different forms for treatment, including surgery, chemotherapy and radiation. There is no data referring to quality of life of patients who are radically operated for pulmonary cancer.

Comparison: multidisciplinary group intervention consisting of exercise training and dyspnoea counseling, 10 times, once a week, compared with one instruction in exercise training and dyspnoea counseling. Exercise training is given by a physiotherapist. Both groups receive in addition standard treatment, which is up to 3 counseling sessions with a nurse.

Eligibility criteria: Inclusion Criteria:

* patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital

Exclusion Criteria:

* not radically operated
* cannot speak and read Danish
* cannot cooperate in tests due to poor mental health
* patients who undergo rehabilitation at other centres
* cannot perform walking test due to physical impairment

Primary outcomes:
measure: Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT
timeFrame: 4 months after inclusion
Secondary outcomes:
measure: Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT
timeFrame: 1 year after inclusion
measure: Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)
timeFrame: 4 months and 1 year after inclusion
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital
Study officials:
affiliation: Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
name: Vitautas Nekrasas, Chief doctor
role: STUDY_CHAIR
References: