Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02580916 |
| Other study ID # |
11054 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
November 2017 |
Study information
| Verified date |
December 2020 |
| Source |
Oxford University Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background:
Patient-reported outcome measures (PROMs) provide validated evidence of health and quality of
life (QoL) from the patient perspective. Several national PROMs programmes have been
implemented in the National Health Service - specifically for common elective procedures.
Local implementation is varied across settings and populations. The incidence of non-melanoma
skin cancer (NMSC) is rapidly increasing, posing considerable burden on UK healthcare
resources, yet there is limited evidence of use of PROMs in NMSC and little information about
patients' perceived health and QoL.
Objectives:
This study will explore feasibility of implementing a skin cancer-specific PROM - Skin Cancer
Quality of Life Impact Tool (SCQOLIT) for NMSC.
Methods:
Three hundred patients with a pathological diagnosis of NMSC undergoing all treatment
modalities will be recruited to complete SCQOLIT questionnaires at baseline, at 3, 6 and 9
months. Participation and response rates, missing data and individual change scores will be
analysed. Staff and patients will be interviewed to explore acceptability and feasibility of
collecting PROMs data.
Results:
Interim results of the project to date will be presented. Feasibility will be assessed by
evaluating number of eligible patients, number of consenting patients, reasons for not
consenting and participant number. Individual longitudinal change in scores, response rates
and psychometric properties of the SCQOLIT will be reported.
Implications:
Acceptability and feasibility of the SCQOLIT tool has never been rigorously assessed in
Dermatology clinics. A validated NMSC-specific PROM would help standardize multi-centred
trials, allow robust evaluation of quality of care and more appropriately direct healthcare
resources to improve QoL in patients with NMSC.
Description:
Background:
Skin cancer is the most rapidly increasing cancer type in fair-skinned populations worldwide.
Although non-melanoma skin cancer (NMSC) are rarely life threatening, both disease and
treatments can be associated with substantial morbidity and confer significant financial
burden to the National Health Service (NHS). Consequently, the British Association of
Dermatologists (BAD) commissioned the Patient-reported Outcomes Measurement Group, Oxford to
review the evidence for PROMs for skin cancer. The authors concluded that cancer-specific
quality of life (QOL) questionnaires appeared more sensitive than generic PROMs e.g. the
Dermatology Life Quality Index (DLQI), in capturing relevant QOL issues. In the NMSC
population, these issues include scarring, disfigurement, anxiety and fear of future skin
cancers.
One skin cancer-specific PROM that was evaluated was the Skin Cancer Quality of Life Impact
Tool (SCQOLIT). The SCQOLIT is a ten-item instrument developed specifically for patients with
non-metastatic skin cancer, which has demonstrated evidence in favour of reproducibility,
validity, internal consistency but requires further evaluation.
The decision to evaluate the SCQOLIT in this study, includes its similarity in overall format
and brevity to that of the DLQI which is a PROM now widely used in routine medical
dermatology clinical practice. The SCQOLIT takes less than five minutes for the patient to
complete and has a similar score calculation to the DLQI. Acceptability and feasibility of
this tool has never been rigorously assessed in Dermatology clinics. Studies evaluating PROMs
in NMSC have been largely assessed in relation to surgical treatments yet basal cell
carcinoma can be effectively treated using medical treatments e.g. topical immunomodulators
and photodynamic therapy, and to date, PROMs have not been investigated in these
sub-populations.
Justification:
This feasibility study is designed to evaluate the SCQOLIT questionnaire, and aims to
establish its utility and impact in patients with NMSC. The investigators will assess both
patient and clinician acceptability of the SCQOLIT questionnaire tool and hope to identify
any unmet needs, which can potentially inform future clinical decisions and/or service
planning.
Study design:
Participants:
All patients referred to Dermatology Tumour outpatient clinics with a clinically suspected
NMSC.
There will be four categories of participants, Groups 1 - 3 are participants with a new
diagnosis of NMSC (primary or recurrent) on any site of the body:
Group 1 (Postal) - this will include those patients with a 'low risk' NMSC (namely basal cell
carcinoma)
Group 2 (Clinic-based) - this will include those patients with a 'moderate to high risk' NMSC
(namely SCC or other rare NMSC)
Group 3 (Interview) - these will be volunteers selected from Groups 1 and 2.
Group 4 (Focus Group: Clinicians) - this will include any Dermatology staff member who is
involved in consenting and collecting PROMS data and has a role for direct care of patients
attending Dermatology outpatient clinics.
