Condition category
Cancer
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Lynn Calman

ORCID ID

Contact details

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

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

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.

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

Methods:
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

Observational

Secondary study design

Multi-centre

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 measures

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

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
research.governance@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes