Condition category
Cancer
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
14/03/2017
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

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 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
+44 161 306 6000
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

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.