Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C10673/A3912
Study information
Scientific title
Acronym
Study hypothesis
Programmes of integrated follow-up co-ordinate activities and resources between primary and secondary care to ensure effective on-going care for patients with specific conditions. This proposal is to develop, implement and evaluate a primary care based integrated follow-up programme for people with cutaneous malignant melanoma. A rigorously evaluated programme for cutaneous malignant melanoma could provide a model for low-tech, efficient, effective and sustainable follow-up programme. Malignant melanoma and primary care have been chosen for the model for several reasons. Melanoma affects both sexes with a disproportionate impact on young people. Most individuals survive for prolonged periods but can experience a recurrence at any time making careful follow-up important. Follow-up consists mainly of clinical examination in contrast to other cancers that need invasive follow-up procedures. Most general practices will have small numbers of patients with melanoma. While this is likely to facilitate primary care based follow-up because of comparatively light workload and resource requirements, it creates challenges in terms of gaining and maintaining expertise.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cutaneous Malignant Melanoma
Intervention
Integrated primary care based follow-up programme for cutaneous malignant melanoma. Intervention comprises general practitioner training, central appointments database, patient education programme, protocol driven reviews in primary care, rapid access pathway to secondary care.
The control group continue to attend follow-up at the Joint Melanoma Clinic, Aberdeen Royal Infirmary. This would be termed 'usual care' as it is the current standard treatment for people treated for melanoma.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Patient satisfaction and adherence to guidelines
Secondary outcome measures
1. Psychological and physical well-being
2. Costs to patients and health services
3. Processes of care
Overall trial start date
01/04/2005
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
People previously treated for cutaneous malignant melanoma.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Non cutaneous melanoma
2. Active recurrence or a recurrence within the last 12 months
3. Terminally ill
4. Mentally ill
5. If their general practitioner believes them to be otherwise unsuitable for participation in the study
Recruitment start date
01/04/2005
Recruitment end date
30/09/2006
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
King's College
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224-272000
sras@abdn.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C10673/A3912)
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
2010 patient satisfaction results in http://www.ncbi.nlm.nih.gov/pubmed/20461089
Publication citations
-
Patient satisfaction results
Murchie P, Nicolson MC, Hannaford PC, Raja EA, Lee AJ, Campbell NC, Patient satisfaction with GP-led melanoma follow-up: a randomised controlled trial., Br. J. Cancer, 2010, 102, 10, 1447-1455, doi: 10.1038/sj.bjc.6605638.