Utility of the Skin Cancer Quality of Life Impact Tool

NCT02580916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2020-12-17

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02580916 on ClinicalTrials.gov