Utility of the Skin Cancer Quality of Life Impact Tool
Condition: Skin Neoplasm; Squamous Cell Carcinoma; Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell; Skin Neoplasms
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): SCQOLIT questionnaire
Intervention type(s): Other
Intervention description(s): 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:
baseline (after histological diagnosis of a NMSC is confirmed - both Groups)
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
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)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: non-melanoma skin cancer; outcome assessment; quality of life