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Trial record 72 of 536 for:    "Skin cancer"

Utility of the Skin Cancer Quality of Life Impact Tool (SCQOLIT)

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ClinicalTrials.gov Identifier: NCT02580916
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Rubeta Matin, Oxford University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Skin Neoplasm Squamous Cell Carcinoma Basal Cell Carcinoma Other: SCQOLIT questionnaire Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) - a Feasibility Study in Non-melanoma Skin Cancer
Study Start Date : July 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: Group 1 (Postal)
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

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)

Experimental: Group 2 (Clinic-based)
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

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)

No Intervention: Group 3 (Interviews)
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.
No Intervention: Group 4 (Clinician focus group)
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.



Primary Outcome Measures :
  1. SCQOLIT questionnaire response rates [ Time Frame: 2 years ]
    Quantitative analysis of patient participation rates in the study, questionnaire response rates and number of missing values.

  2. Qualitative analysis of patient and staff preferences, views and experiences [ Time Frame: 2 years ]
    Analysis of structured interviews and focus group to establish acceptability of SCQOLIT tool


Secondary Outcome Measures :
  1. Construct validity of SCQOLIT tool [ Time Frame: 2 years ]
    Measure of psychometric property of SCQOLIT

  2. Responsiveness of SCQOLIT tool [ Time Frame: 2 years ]
    Measure of psychometric property of SCQOLIT

  3. Differences in scores from baseline to follow-up [ Time Frame: 2 years ]
    Measure of psychometric property of SCQOLIT - clinically important difference. A statistical analysis of the differences in scores will be calculated.

  4. Proportion of responses at the uppermost and lowermost end of the scale [ Time Frame: 2 years ]
    Measure of psychometric property of SCQOLIT - floor and ceiling effect - to evaluate the range of scores and to determine how many responses are at the highest and lowest scores.

  5. Intra- and inter- participant change in scores [ Time Frame: 2 years ]
    Measure of psychometric property of SCQOLIT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580916


Locations
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United Kingdom
Churchill Hospital
Headington, Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
University of Oxford
Investigators
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Principal Investigator: Rubeta N Matin Oxford University Hospitals NHS Trust

Additional Information:
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Responsible Party: Rubeta Matin, Consultant Dermatologist, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02580916     History of Changes
Other Study ID Numbers: 11054
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Keywords provided by Rubeta Matin, Oxford University Hospitals NHS Trust:
non-melanoma skin cancer
outcome assessment
quality of life

Additional relevant MeSH terms:
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Skin Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases