Plain English Summary
http://www.cancerhelp.org.uk/trials/a-study-of-follow-up-care-after-treatment-for-lung-cancer
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6073; MRC G0601695
Study information
Scientific title
Living well with lung cancer: evaluating the effectiveness of a sustainable model of follow-up care
Acronym
Study hypothesis
Aims:
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
South Manchester Research Ethics Committee, 24/06/2009, ref: 09/H1003/72
Study design
Multicentre observational process of care qualitative study
Primary study design
Observational
Secondary study design
Case series
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell)
Intervention
Stage 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Quality of life
2. Symptom control
3. Patient satisfaction
Secondary outcome measures
1. Survival
2. Economic evaluation
Overall trial start date
01/11/2009
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 100; UK sample size: 100
Participant exclusion criteria
Patients with a diagnosis of mesothelioma will be excluded at this stage due to complexities of disease management.
Recruitment start date
01/11/2009
Recruitment end date
30/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Research Fellow
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 6000
research.governance@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0601695)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list