Utility of the skin cancer quality of life impact tool (SCQOLIT)
| ISRCTN | ISRCTN15839666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15839666 |
| ClinicalTrials.gov number | NCT02580916 |
| Secondary identifying numbers | 20564 |
- Submission date
- 03/02/2016
- Registration date
- 03/02/2016
- Last edited
- 04/01/2021
- 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 Rubeta Matin
Public
Public
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
| Phone | +44 1865 572971 |
|---|---|
| rubeta.matin@ouh.nhs.uk |
Study information
| Study design | Prospective non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) – a feasibility study in nonmelanoma skin cancers |
| Study objectives | 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(s) | Oxford B Research Ethics Committee, 18/06/2015, ref: 14/SC/1446 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2015 |
| Completion date | 30/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Total final enrolment | 318 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Headington
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Oxford University Hospitals NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Research & Development Office
Joint Research Office
Block 60
Churchill Hospital
Headington
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
Funders
Funder type
Research council
Medical Research Council
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Oxfordshire Health Services Research Committee
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at ISOQOL in : | 01/10/2016 | 29/04/2019 | No | No |
| Abstract results | results presented at the 97th Annual Meeting of the British Association of Dermatologists in : | 30/11/2017 | 29/04/2019 | No | No |
| Results article | results | 01/03/2020 | 04/01/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/01/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
29/04/2019: Publication reference added.
16/04/2019: No publications found, verifying study status with principal investigator.
17/03/2016: Internal review.
18/02/2016: Verified study information with principal investigator.
