Condition category
Cancer
Date applied
27/05/2011
Date assigned
27/05/2011
Last edited
21/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Amy Bradley

ORCID ID

Contact details

Critical Care MIDRU
Birmingham Heartlands Hospital
Bordersley Green East
Birmingham
B9 5SS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9448

Study information

Scientific title

A study of rehabilitation in patients taking part in the operated lung cancer programme in comparison to the non intervention group

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

First MREC approval date 21/07/2010 ref 10/H1208/41

Study design

Non-randomised interventional and Observational qualitative trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2011

Overall trial end date

01/04/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

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 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

United Kingdom

Trial participating centre

Critical Care MIDRU
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Heart of England NHS Foundation Trust

Sponsor details

3 Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.heartofengland.nhs.uk/

Funders

Funder type

Charity

Funder name

The Health Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23959742

Publication citations

  1. Results

    Bradley A, Marshall A, Stonehewer L, Reaper L, Parker K, Bevan-Smith E, Jordan C, Gillies J, Agostini P, Bishay E, Kalkat M, Steyn R, Rajesh P, Dunn J, Naidu B, Pulmonary rehabilitation programme for patients undergoing curative lung cancer surgery., Eur J Cardiothorac Surg, 2013, 44, 4, e266-71, doi: 10.1093/ejcts/ezt381.

Additional files

Editorial Notes