A study of Rehabilitation in patients taking part in the Operated Lung Cancer Programme in comparison to the non intervention group
| ISRCTN | ISRCTN00061628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00061628 |
| Secondary identifying numbers | 9448 |
- Submission date
- 27/05/2011
- Registration date
- 27/05/2011
- Last edited
- 25/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Miss Amy Bradley
Scientific
Scientific
Critical Care MIDRU
Birmingham Heartlands Hospital
Bordersley Green East
Birmingham
B9 5SS
United Kingdom
Study information
| Study design | Non-randomised interventional and Observational qualitative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A study of rehabilitation in patients taking part in the operated lung cancer programme in comparison to the non intervention group |
| Study acronym | ROC |
| Study hypothesis | The study aims to examine whether a rehabilitation programme that identifies potential surgical candidates several weeks before surgery and optimises their physical status, prepare them for the inpatient journey and support their recovery after surgery, reduces: 1. In patient length of stay 2. Reduced rate of Pulmonary Complication (PPC) 3. Reduced ITU and HDU admissions 4. Increased patient quality of life 5. Deliver cost savings |
| Ethics approval(s) | First MREC approval date 21/07/2010, ref 10/H1208/41 |
| Condition | Lung cancer (small cell & non-small cell) |
| Intervention | 1. Rehabilitation for Operated lung Cancer (ROC) programme 2. Pulmonary rehabilitation 3. Smoking cessation 4. Dietary advice 5. Patient self-management 6. Follow up length: 5 month(s) 7. Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure | 1. Reduced inpatient length of stay 2. Timepoint(s): discharge from hospital |
| Secondary outcome measures | 1. Increased patient quality of life, timepoint(s): 5 months from surgery 2. Reduced ITU and admissions, timepoint(s): discharge 3. Reduced rate of Pulmonary Complication (PPC), timepoint(s): discharge |
| Overall study start date | 01/04/2011 |
| Overall study end date | 01/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Total of 1275 patients will be recruited into the study, 850 control and 425 case patients over 5 years |
| Participant inclusion criteria | 1. All Patients undergoing curative lung resections for lung cancer 2. Patients that are equal to 18 years old or over 3. Patients willing to give consent 4. Patients treated by Heart of England Foundation NHS Trust (Heartlands and Solihull Hospital not Good Hope Hospital 5. Patients treated by Worcestershire Acute Hospitals Trust (Worcester Royal Hospital) 6. Target gender: male & female 7. Lower age limit 18 years |
| Participant exclusion criteria | Patients referred from 1. Heart of England Foundation NHS Trust, Good Hope Hospital 2. Worcestershire Acute Hospitals NHS Trust, Redditch Hospital 3. University Hospitals Birmingham Foundation NHS Trust 4. Sandwell and West Birmingham Hospitals NHS Trust 5. Gloucestershire Hospitals NHS Foundation NHS Trust 6. Hereford Hospital NHS Trust 7. Walsall Hospitals NHS Trust |
| Recruitment start date | 01/04/2011 |
| Recruitment end date | 01/04/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Critical Care MIDRU
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Sponsor information
Heart of England NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
3 Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
England
United Kingdom
| Website | http://www.heartofengland.nhs.uk/ |
|---|
Funders
Funder type
Charity
The Health Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 01/05/2019 | 25/02/2019 | Yes | No |
Editorial Notes
25/02/2019: Publication reference added.
