Utility of the Skin Cancer Quality of Life Impact Tool

NCT02580916 | Completed

• 1 other identifier: 11054
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-melanoma skin cancer; outcome assessment; quality of life

Outcome Measures

Primary Outcomes (2)

• SCQOLIT questionnaire response rates

  Quantitative analysis of patient participation rates in the study, questionnaire response rates and number of missing values.

  2 years

• Qualitative analysis of patient and staff preferences, views and experiences

  Analysis of structured interviews and focus group to establish acceptability of SCQOLIT tool

  2 years

Secondary Outcomes (5)

• Construct validity of SCQOLIT tool

  2 years

• Responsiveness of SCQOLIT tool

  2 years

• Differences in scores from baseline to follow-up

  2 years

• Proportion of responses at the uppermost and lowermost end of the scale

  2 years

• Intra- and inter- participant change in scores

  2 years

Study Arms (4)

Group 1 (Postal)

EXPERIMENTAL

These are patients who will be identified from the histological diagnosis of their skin cancer by members of the direct care team and deemed 'low risk'; SCQOLIT questionnaires will be administered by post.

Other: SCQOLIT questionnaire

Group 2 (Clinic-based)

EXPERIMENTAL

These are patients who will be identified from the histological diagnosis of their skin cancer by members of the direct care team, for whom all aspects of the study will be conducted in the Dermatology clinic. SCQOLIT questionnaires will be administered according to the protocol.

Other: SCQOLIT questionnaire

Group 3 (Interviews)

NO INTERVENTION

A Qualitative Researcher (Co-Investigator) will undertake structured interviews with approximately 20 patients from both Group 1 and 2. Potential participants will be invited to volunteer their contact details at the time of consent to the Questionnaire study. This is optional; they may refuse to do so and still take part in the main questionnaire study. The patient will then be contacted by the Qualitative Researcher (Co-Investigator) at a later date and subsequently consented for the interview.

Group 4 (Clinician focus group)

NO INTERVENTION

We aim to discuss the project at the end of the study period in the same setting, to establish staff perspectives on the study, to establish usefulness of the SCQOLIT tool and to identify any barriers to implementation.

Interventions

SCQOLIT questionnaire OTHER

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)

Group 1 (Postal); Group 2 (Clinic-based)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged over 18 yrs old
• All patients with a histopathological diagnosis of NMSC (primary or recurrent disease)
• All treatments used for NMSC will be included; excision, shave excision, curettage and cautery, Mohs micrographic surgery, photodynamic therapy and topical treatments e.g. imiquimod cream.

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Concurrent internal malignancy as this is likely to significantly influence QOL.
• Patients referred onwards to other specialties for management of their skin cancer e.g. Plastic surgeons / Clinical oncology.
• Other significant dermatological diseases e.g. severe inflammatory or blistering skin conditions as this may influence QOL.
• Inability to consent for themselves.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Oxford: collaborator

Study Sites (1)

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms, Basal Cell

Study Officials

• Rubeta N Matin

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Dermatologist

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: October 20, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

GB (1)