Lung CancerPROMISENCT05136300
Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer
A study testing Pulmonary rehabilitation in people with Lung Cancer and Surgery, run by Isala at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Surgery
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2019to 1 Jul 2023
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective, minimal invasive surgery with intention to cure.
- Age between 18 and 80 years.
- ECOG 0 - 2 post-surgery.
Who cannot join
- Patients with chronic pain
- Previous pulmonary surgery
- Comorbidity limiting rehabilitation
- Rheumatoid arthritis
- Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
- Muscle disease
Show all 9Show fewer
- Fibromyalgia
- Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer, Surgery
- Being tested
- Pulmonary rehabilitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationBehavioural
Also called Pain clinic
Patients in the intervention group will receive physical therapy, scheduled pain monitoring and coaching by a social worker.
The intensity of the rehabilitation training program will be determined separately for each patient by a steepramp and 1-repetition test within 3 weeks post-operative. The intervention group will be trained and educated in 2 sessions of 2 hours per week, for a period of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Pulmonary rehabilitation |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (SF-36)
effects of an integrated multidisciplinary rehabilitation program on general quality of life
Measured: 12 months
Secondary outcomes (5)
SGRQ
health-related quality of life
Measured: 12 months
VAS
post-operative pain
Measured: 12 months
WHO-PS
performance score
Measured: 12 months
6 minute walking distance
exercise tolerance
Measured: 12 months
international physical activity questionnaire, iPAQ
physical activity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 May 2019
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Dinjens, Isala
- Investigators
- J Stigt, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136300
- Sponsor's protocol ID
- ABR 63724
- Acronym
- PROMISE
- Status last verified
- Aug 2022
- First submitted
- 17 Nov 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer
- ClinicalTrials.gov ID
- NCT05136300
- Acronym / sponsor ID
- PROMISE / ABR 63724
- Conditions
- Lung Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 29 Nov 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pulmonary rehabilitationAn 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 |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective, minimal invasive surgery with intention to cure.
- Age between 18 and 80 years.
- ECOG 0 - 2 post-surgery.
Key exclusion criteria (9 listed)
- Patients with chronic pain
- Previous pulmonary surgery
- Comorbidity limiting rehabilitation
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 |
|---|---|---|
| Pulmonary rehabilitationAlso: Pain clinicPatients in the intervention group will receive physical therapy, scheduled pain monitoring and coaching by a social worker. The intensity of the rehabilitation training program will be determined separately for each patient by a steepramp and 1-repetition test within 3 weeks post-operative. The intervention group will be trained and educated in 2 sessions of 2 hours per week, for a period of 3 months. | Behavioural | Intervention |
Primary outcome
Quality of life (SF-36)
Time frame: 12 months
effects of an integrated multidisciplinary rehabilitation program on general quality of life
5 secondary outcomes
SGRQ
Time frame: 12 months
VAS
Time frame: 12 months
WHO-PS
Time frame: 12 months
6 minute walking distance
Time frame: 12 months
international physical activity questionnaire, iPAQ
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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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.
J Stigt principal investigator
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Lung Cancer and Surgery, run by Isala at 1 site in Netherlands.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Dinjens (0384244597, ldinjens@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (SF-36) (time frame: 12 months). 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 3 Aug 2022.