ISRCTN ISRCTN30820196
DOI https://doi.org/10.1186/ISRCTN30820196
Secondary identifying numbers 6073; MRC G0601695
Submission date
12/05/2010
Registration date
12/05/2010
Last edited
29/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-study-of-follow-up-care-after-treatment-for-lung-cancer

Contact information

Dr Lynn Calman
Scientific

MRC Research Fellow
School of Nursing, Midwifery and Social Work
The University of Manchester
Jean McFarlane Building
University Place
Oxford Road
Manchester
M13 9PL
United Kingdom

Study information

Study designMulticentre observational process of care qualitative study
Primary study designObservational
Secondary study designCase series
Study setting(s)GP practice
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleLiving well with lung cancer: evaluating the effectiveness of a sustainable model of follow-up care
Study objectivesAims:
1. To develop a sustainable model of follow-up service delivery
2. To determine if the model is potentially beneficial (proof of concept) through an exploratory (feasibility) trial with outcomes focused on quality of life, patient satisfaction and cost effectiveness
Ethics approval(s)South Manchester Research Ethics Committee, 24/06/2009, ref: 09/H1003/72
Health condition(s) or problem(s) studiedTopic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell)
InterventionStage one: developing the intervention -
In order to develop a robust evidence based intervention this project is designed using steps of the MRC framework for developing and evaluating complex interventions (MRC 2000/2007). The first stage of this framework is to develop the intervention using primarily qualitative methods, once the intervention has been developed a feasibility trial will be designed.
Intervention typeOther
Primary outcome measure1. Quality of life
2. Symptom control
3. Patient satisfaction
Secondary outcome measures1. Survival
2. Economic evaluation
Overall study start date01/11/2009
Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 100; UK sample size: 100
Total final enrolment31
Key inclusion criteria1. Completed initial treatment for lung cancer
2. Suitable for nurse-led follow-up (as defined in Stage 1)
3. Physically and psychologically able and willing to complete outcome measures
4. Not taking part in any other clinical trial
5. Age restrictions will not be imposed, both male and female participants will be recruited
Key exclusion criteriaPatients with a diagnosis of mesothelioma will be excluded at this stage due to complexities of disease management.
Date of first enrolment01/11/2009
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Research Fellow
Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone +44 161 306 6000
Email research.governance@manchester.ac.uk
Website http://www.manchester.ac.uk/
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0601695)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Plain English results 08/01/2014 29/03/2022 No Yes

Editorial Notes

E29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
14/03/2017: No publications found in PubMed, verifying study status with principal investigator
22/02/2011: The anticipated end date for this trial has been updated from 30/12/2010 to 30/04/2011.