Condition category
Cancer
Date applied
25/08/2005
Date assigned
19/10/2005
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Murchie

ORCID ID

Contact details

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

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 measures

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

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

http://www.abdn.ac.uk/idx.php

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

Results - basic reporting

Publication summary

2010 patient satisfaction results in http://www.ncbi.nlm.nih.gov/pubmed/20461089

Publication citations

  1. 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.

Additional files

Editorial Notes