Plain English Summary
Background and study aims:
As a country, we are making efforts to diagnose lung cancer at the earliest possible stage, because we believe that this will increase options for treatment and improve chances of survival. Not only do we have to take action within the health service to speed up investigations, but we must also find ways to make sure that people with important symptoms seek help quickly. Nearly all people with lung cancer have symptoms for many weeks before seeing a doctor. These symptoms are not very remarkable and usually are not lung cancer, but they are worth investigating if they persist.
This project aims to evaluate whether an educational programme, designed with the help of patients and specialists to be delivered in general practice, can reduce the time people take to see a doctor when they develop important symptoms.
Who can participate?
Patients registered at two general practices in Northeast Scotland, who are aged 55 years or older and are, or have been, heavy smokers.
What does the study involve?
The study is a randomized trial. This means that people who enroll in the trial will be divided into two groups. They will have to accept an equal and random chance of being allocated to one or other group and will not be allowed to choose. One group will receive the new educational programme. This involves a consultation with a nurse at their general practice and a self help manual to take home. The other group will not receive the educational programme, but will receive all their usual care at their general practice. All people in the trial will be asked to complete questionnaires at the beginning and after one and six months. They will also have data collected from their general practice case notes on consultations they make at the practice during the year before and after the start of the trial.
What are the possible benefits and risks of participating?
We dont expect any large benefits or risks from participating in the study. People who receive the educational programme may find it helpful; some may find it worrying, we wont find out until after the study.
Where is the study run from?
The Centre of Academic Primary Care, University of Aberdeen.
When is study starting and how long is it expected to run for?
The trial started on 1 August 2007 and ran for three years. Recruitment for the trial commenced in mid 2008 and the trial ended 18 months later.
Who is funding the study?
Cancer Research UK
Who is the main contact?
Neil Campbell
n.campbell@abdn.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Neil Campbell
ORCID ID
Contact details
Centre of Academic Primary Care
University of Aberdeen
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom
+44 (0)1224 554241
n.campbell@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PRGS/043/07
Study information
Scientific title
Reducing time to presentation with symptoms of lung cancer: phase II complex intervention study
Acronym
Study hypothesis
A theoretically-based educational intervention in primary care has potential to reduce time between onset of, and presentation with, lung cancer symptoms.
Ethics approval
North of Scotland Research Ethics Committee, 14/06/2007, ref: 07/SO801/45
Study design
Phase ll randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Lung cancer (and other lung diseases)
Intervention
A complex intervention to be delivered in two general practices (rural and urban), targeted at 210 high risk patients (greater than 55 years, smokers and ex-smokers). The intervention has been developed using a causal modelling approach and uses evidence-based behavioural interventions. Key components will:
1. Increase the salience and personal relevance of symptoms
2. Improve knowledge of symptoms
3. Reinforce the benefits of early intervention in lung cancer and other lung diseases
4. "Sanction" early consultation and encourage sanctioning by others
5. Tackle barriers to consulting, and
6. Provide personalised action plans
To optimise implementation a focus group study will identify barriers and facilitators. A phase II randomised trial will evaluate how the intervention affects consulting behaviour. Qualitative parallel interviews with 10 professionals, 10 participants in the randomised trial, and 10 additional patients exposed to intervention will explore positive and negative reactions to the intervention.
Computer generated random numbers will be used to allocate half the participants at each general practice into intervention and control groups. We will stratify by practice because consulting behaviour differs in rural and urban areas. The trial will be open to participants, who will be aware of whether they have been invited to the intervention or not. Quantitative data collection and entry will, however, be conducted blind to group allocation. Intervention participants will be asked to attend a single nurse consultation. They will be provided with the manual to keep. Our control group will receive usual primary care. All participants will complete questionnaires at three time points: baseline, one month, and six months. Additionally, participants will be asked to complete a short questionnaire each time they consult general practice with respiratory symptoms. The study period for each participant will last approximately six months. Data on total general practice consultations, and chest X-ray and hospital referrals/appointments will be collected from general practice case notes. Quantitative data will be entered anonymously onto an Access database. 10% will be second keyed and discrepancies noted. Descriptive statistics will be used for recruitment rates. For trial outcomes, control and intervention groups will be compared using the chi-square and t-tests and multiple logistic and linear regression used to adjust for general practice and other relevant confounders. Transformations and non-parametric tests will be used where appropriate. Transcribed qualitative data from interviews will be analysed to identify themes that can inform the overall research process as well as questionnaire and intervention content. Data on the research process, including suggestions on improvements will be collated and taken into consideration in development of any future phase III trial.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Proportions of participants consulting within a week of haemoptysis or four weeks of other guideline symptoms (symptoms recommended for investigation in SIGN or Cancer Research UK guidelines on lung cancer) during the six-month period of follow up.
Secondary outcome measures
Measured by postal questionnaire at baseline, one month and six months:
1. Intentions to consult under various conditions - using methods found to give valid and reliable results
2. Self efficacy - questions adapted from standard measures, taking account of barriers to consultation identified during focus groups
3. Knowledge of symptoms and risk factors - using questions developed during our previous study
4. Cancer worry scale - a six-item scale found to have good reliability (most recently Cronbach's a = 0.83 and test-retest reliability = 0.74)
5. Hospital Anxiety and Depression questionnaire
Measured at other timepoints:
6. Reasons for consultation will be investigated using short questionnaires after each consultation (explanations for symptoms considered, expectations from consultation, prompts received to consult, and resources used to decide)
7. Health service use (general practice consultations, and chest X-ray and hospital referrals/appointments) will be collected from general practice case notes at the end of the study period
8. Trial process outcomes. Recruitment rates, response rates, and problems encountered during recruitment, implementation of the intervention, and data collection will be noted throughout the course of the study.
Overall trial start date
01/08/2007
Overall trial end date
31/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Long-term smokers (at least 20 pack years) aged 55 years or over, either sex, including ex-smokers if their cessation date is within 10 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
210
Participant exclusion criteria
1. Housebound
2. Terminally ill
3. Have dementia
Recruitment start date
01/08/2007
Recruitment end date
31/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Aberdeen
AB25 2AY
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
Research and Innovation
King's College
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 272123
res-innov@abdn.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C542/A8695)
Alternative name(s)
CRUK
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
Basic results (scientific)
Publication list
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23336469