Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Lynn Calman


Contact details

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

Additional identifiers

EudraCT number 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


Study hypothesis

Lung cancer is the leading cause of cancer death in the UK. Primary treatment has curative intent only in about 10% of cases. There is currently little evidence that suggests what type of follow-up is most beneficial to patients, or cost effective, after initial treatment. Follow-up is important so appropriate second line treatment or supportive or palliative care can be introduced. Innovative methods of follow-up have been developed in other types of cancer, these have been successful at delivering similar outcomes and patient satisfaction as traditional hospital based follow-up.

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

A systematic review and meta-analysis of interventions for the follow-up of lung cancer patients has been undertaken to clarify what interventions have already been developed and evaluated. In developing the model, we will address patient and carer need, suitability for nurse-led follow-up, training needs of nurses, links between secondary and primary care, referral protocols and guidelines, economic and organisational factors. A review of current practice will be conducted at the study sites to determine the aim and method of standard follow-up. A scoping exercise will examine current models of practice, protocols and guidelines, instigated by communication with the National Lung Cancer Nurse Forum.

The MRC framework for the development and evaluation of complex interventions will be used to guide the study and develop a robust intervention. The intervention will be tested in a pilot trial. The outcome measures of this study will focus on quality of life, symptom control and patient satisfaction but will include survival and economic evaluation as secondary outcome measures.

As of 22/02/2011 the anticipated end date for this trial has been updated from 30/12/2010 to 30/04/2011.

Ethics approval

South Manchester Research Ethics Committee on 24/06/2009 (ref: 09/H1003/72)

Study design

Multicentre observational process of care qualitative study

Primary study design


Secondary study design


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


Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell)


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



Not Applicable

Drug names

Primary outcome measures

1. Quality of life
2. Symptom control
3. Patient satisfaction

Secondary outcome measures

1. Survival
2. Economic evaluation

Overall trial start date


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

MRC Research Fellow
M13 9PL
United Kingdom

Sponsor information


University of Manchester (UK)

Sponsor details

Oxford Road
M13 9PL
United Kingdom

Sponsor type




Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0601695)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes