Utility of the Skin Cancer Quality of Life Impact Tool
NCT02580916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318
Last updated 2020-12-17
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.
Conditions
- Skin Neoplasm
- Squamous Cell Carcinoma
- Basal Cell Carcinoma
Interventions
- OTHER
-
SCQOLIT questionnaire
Participants will be invited to complete the SCQOLIT and EQ-5D (used for comparison purposes, given its widespread use in other healthcare contexts in the UK) questionnaires \[Appendices C \& D) at: 1. baseline (after histological diagnosis of a NMSC is confirmed - both Groups) 2. 3 months - either by postal (Group 1) or face-to-face (Group 2) dependent on whether the patient is returning to the Dermatology clinic for routine follow-up 3. at 6-9 months in the dermatology clinic if the patient is deemed high risk (squamous cell carcinoma with high risk clinicopathological features as listed by the National British Association Dermatologists Multiprofessional Guidelines for management of SCC) (Group 2 only)
Sponsors & Collaborators
-
University of Oxford
collaborator OTHER -
Oxford University Hospitals NHS Trust
lead OTHER
Principal Investigators
-
Rubeta N Matin · Oxford University Hospitals NHS Trust
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2017-08-31
- Completion
- 2017-11-30
Countries
- United Kingdom
Study Locations
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