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Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pulmonary Cancer

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Trial Information

Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Outcome Measure:

Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT

Outcome Time Frame:

4 months after inclusion

Safety Issue:

No

Principal Investigator

Vitautas Nekrasas, Chief doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

Tp.afd-001

NCT ID:

NCT01048762

Start Date:

February 2006

Completion Date:

September 2010

Related Keywords:

  • Pulmonary Cancer
  • pulmonary cancer
  • radically operated
  • exercise training
  • dyspnea counseling
  • quality of life
  • physical therapy
  • Lung Neoplasms

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