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
Secondary identifying numbers 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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesProgrammes 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) studiedCutaneous Malignant Melanoma
InterventionIntegrated 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 typeOther
Primary outcome measurePatient satisfaction and adherence to guidelines
Secondary outcome measures1. Psychological and physical well-being
2. Costs to patients and health services
3. Processes of care
Overall study start date01/04/2005
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteriaPeople previously treated for cutaneous malignant melanoma.
Key exclusion criteria1. 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 enrolment01/04/2005
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University of Aberdeen
Aberdeen
AB25 2AY
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom

Phone +44 (0)1224-272000
Email sras@abdn.ac.uk
Website http://www.abdn.ac.uk/idx.php
ROR logo "ROR" https://ror.org/016476m91

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C10673/A3912)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
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