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.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effects on quality of life will be our main endpoint, this will be tested with
the following questionnaires: short form health survey (SF-36),
Secondary outcome
- Pulmonary health related quality of life (SGRQ score)
- Acute / chronic score (VAS)
- Impairment (changes in pulmonary function)
- Performance score (WHO)
- Disability / exercise capacity (6MWD and iPAQ)
Background summary
A lobectomy or pneumonectomy is an operation with curative intention in a
selected population with lung cancer. After the operation the disease is
considered as cured but recovery of the patient takes more time. The physical,
mental and social problems associated with the disease and treatment are just
at their beginning. Physical complaints as pain and loss of exercise tolerance
are a limiting factor (2-4). Disability to participate in the daily routine,
social life and work will lead to impairment in the social context. Mental and
psychological effects due to the confrontation with health failure may increase
disease burden.
All these different domains are related to the patients* quality of life (QOL).
Previous reports showed a decrease in QOL during the first 6 months after
surgery, with recovery afterwards (5,6). The multifactorial postoperative
problems ask for an integral approach with patient centred care from different
perspectives: multidisciplinary rehabilitation.
In 2013 we conducted a study in our hospital to investigate post-operative
rehabilitation in lung cancer. In a randomised controlled trial patients
undergoing thoracotomy received additional care and treatment of physical
therapists, the pain clinic and social workers to investigate the effect on
QOL(1). The main finding was an increased exercise tolerance without an
increase in QOL. The intervention group experienced more pain, which had a
negative effect on QOL. The increase in pain was explained due to the extensive
and mutilating operating technique of thoracotomy. As a result, we did not
implement multidisciplinary rehabilitation as standard care.
Since 2013 the thoracotomy has been replaced by minimal invasive surgery (MIS).
Video-assisted thoracoscopic (VATS) and robot-assisted thoracoscopic surgery
are the new standard operating techniques. A recently randomised control trial
showed improvement in both post-operative pain levels and QOL after VATS
compared to thoracotomy (7).
These findings associated with the minimal invasive surgery opens new
opportunities for multidisciplinary rehabilitation.
Study 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.
Intervention
The intervention group is given an integrated multidisciplinary rehabilitation
program consisting of extensive physical training program for 3 months, visits
to the pain clinic, visits to the social worker and, if indicated to the
psychologist.
Study burden and risks
Our intervention group will follow a prespecified 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. There will be no additional number of
blood samples. Our trial nurse will guard the physiological and physical burden
associated with our study by frequently contacting the patients.
dr. van Heesweg 2
Zwolle 8025 AB
NL
dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
lungcancer
minimal invasive pulmonary surgery
age between 18 - 80 years
ECOG 0 - 2 post-operative
Exclusion criteria
1. Patients with chronic pain
2. Previous pulmonary surgery
3. Comorbidity limiting rehabilitation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL63724.075.18 |