Condition category
Cancer
Date applied
03/02/2016
Date assigned
03/02/2016
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Public

Primary contact

Dr Rubeta Matin

ORCID ID

Contact details

Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
+44 1865 572971
rubeta.matin@ouh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02580916

Protocol/serial number

20564

Study information

Scientific title

Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) – a feasibility study in non­melanoma skin cancers

Acronym

Study hypothesis

The aim of this study is to explore the practicality and value of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) for non-melanoma skin cancer (NMSC) to patients and clinicians in the dermatology clinical setting.

Ethics approval

Oxford B Research Ethics Committee, 18/06/2015, ref: 14/SC/1446

Study design

Prospective non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer, Dermatology; Subtopic: Melanoma, Skin (all Subtopics); Disease: Skin, Dermatology

Intervention

Three hundred patients (100 with squamous cell carcinoma, 200 with basal cell carcinoma) identified in Dermatology outpatient clinics will be recruited to complete SCQOLIT questionnaires at baseline (after histological confirmation of NMSC), at 3 months (by postal or face:face) and at 6-9 months (high risk patients only). Structured interviews with twenty patients and focus group work with 10-15 Dermatology staff will establish acceptability of the SCQOLIT and identify any barriers to implementation. Both quantitative and qualitative analyses will be undertaken.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Acceptability of SCQOLIT tool as determined by analysis of patients participation rates and qualitative analysis of patient and staff preferences at the end of the study.

Secondary outcome measures

Psychometric properties of SCQOLIT tool are measured at baseline, 3 months and 6-9 months.

Overall trial start date

01/07/2015

Overall trial end date

30/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or above
2. Participant is willing and able to give informed consent for participation in the study.
3. All patients with a histopathological diagnosis of NMSC (primary or recurrent disease)
4. All treatments used for NMSC will be included in the study; excision, shave excision, curettage and cautery, Mohs micrographic surgery, photodynamic therapy and topical treatments e.g. imiquimod cream

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. Concurrent internal malignancy as this is likely to significantly influence quality of life (QOL)
2. Patients referred on to other specialties for management of their skin cancer e.g. Plastic surgeons / Clinical oncology
3. Other significant dermatological diseases e.g. severe inflammatory or blistering skin conditions as this may influence QOL
4. Inability to consent for themselves

Recruitment start date

01/07/2015

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
Old Road Headington
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Oxford University Hospitals NHS Trust

Sponsor details

Research & Development Office
Joint Research Office
Block 60
Churchill Hospital
Headington
OX3 7LE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Oxfordshire Health Services Research Committee

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be disseminated at national and international Dermatology/Skin Cancer meetings and publishing in a high impact peer reviewed journal.

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/03/2016: Internal review. 18/02/2016: Verified study information with principal investigator.