Pulmonary CancerPhase 2NCT01048762
Multidisciplinary Rehabilitation After Cancer Pulmonis Operation
A Phase 2 study testing physical exercise and dyspnoea counseling and home training in people with Pulmonary Cancer, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Cancer
- What is being tested?
- physical exercise and dyspnoea counseling and home training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital
Aalborg, 9100
About this study
Official title: Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pulmonary Cancer
- Being tested
- physical exercise and dyspnoea counseling, home training
- Keywords
- pulmonary cancer, radically operated, exercise training, dyspnea counseling, quality of life, physical therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercise and dyspnoea counselingOther
Also called aerobic exercise training and resistance training, dyspnea counseling, training in groups
Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.
home trainingOther
Also called home based exercises
one instruction in home based exercise training
| Study group | Role | What they receive |
|---|---|---|
| supervised exercise training | Active comparator | Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training Receives: Other: physical exercise and dyspnoea counseling; Other: home training |
| one instruction on homebased exercises | Sham comparator | One instruction on home based exercise training and dyspnea management Receives: Other: home training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT
Measured: 4 months after inclusion
Secondary outcomes (2)
Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT
Measured: 1 year after inclusion
Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)
Measured: 4 months and 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startFeb 2006
- Primary completionJan 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, The Danish Cancer Foundation - Research Department - North Region, University of Aarhus
- Responsible party
- Principal investigator, Barbara C. Brocki, Aalborg University Hospital
- Investigators
- Vitautas Nekrasas, Chief doctor, Study chair, Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048762
- Sponsor's protocol ID
- Tp.afd-001
- Status last verified
- Oct 2015
- First submitted
- 13 Jan 2010
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01048762
- Acronym / sponsor ID
- Tp.afd-001
- Conditions
- Pulmonary Cancer
- Keywords
- pulmonary cancer, radically operated, exercise training, dyspnea counseling, quality of life, physical therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, The Danish Cancer Foundation - Research Department - North Region, University of Aarhus
- Study start
- Feb 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supervised exercise training | Active comparator | Other: physical exercise and dyspnoea counseling, Other: home trainingIntervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training |
| one instruction on homebased exercises | Sham comparator | Other: home trainingOne instruction on home based exercise training and dyspnea management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercise and dyspnoea counselingAlso: aerobic exercise training and resistance training, dyspnea counseling, training in groupsExercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week. | Other | supervised exercise training |
| home trainingAlso: home based exercisesone instruction in home based exercise training | Other | one instruction on homebased exercises, supervised exercise training |
Primary outcome
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT
Time frame: 4 months after inclusion
2 secondary outcomes
Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT
Time frame: 1 year after inclusion
Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)
Time frame: 4 months and 1 year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitautas Nekrasas, Chief doctor study chair
Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing physical exercise and dyspnoea counseling and home training in people with Pulmonary Cancer, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT (time frame: 4 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.