Development, implementation and evaluation of an integrated follow-up programme for people with cutaneous malignant melanoma

ISRCTN	ISRCTN71577271
DOI	https://doi.org/10.1186/ISRCTN71577271
Protocol serial number	C10673/A3912
Sponsor	University of Aberdeen (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C10673/A3912)

Submission date: 25/08/2005
Registration date: 19/10/2005
Last edited: 10/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Murchie
Scientific

University of Aberdeen
Department of General Practice and Primary Care
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Patient satisfaction and adherence to guidelines
Key secondary outcome measure(s)	1. Psychological and physical well-being 2. Costs to patients and health services 3. Processes of care
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key inclusion criteria	People previously treated for cutaneous malignant melanoma.
Key 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
Date of first enrolment	01/04/2005
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University of Aberdeen

Aberdeen
AB25 2AY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	patient satisfaction results	11/05/2010		Yes	No