Skin NeoplasmSCQOLITNCT02580916
Utility of the Skin Cancer Quality of Life Impact Tool
A study testing SCQOLIT questionnaire in people with Skin Neoplasm and Squamous Cell Carcinoma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Skin Neoplasm, Squamous Cell Carcinoma, Basal Cell Carcinoma
- What is being tested?
- SCQOLIT questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) - a Feasibility Study in Non-melanoma Skin Cancer
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.
Read more
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.
Read the 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.
- Conditions
- Skin Neoplasm, Squamous Cell Carcinoma, Basal Cell Carcinoma
- Being tested
- SCQOLIT questionnaire
- Keywords
- non-melanoma skin cancer, outcome assessment, quality of life
- Medical subject headings
- Skin Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCQOLIT questionnaireOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCQOLIT questionnaire response rates
Quantitative analysis of patient participation rates in the study, questionnaire response rates and number of missing values.
Measured: 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
Measured: 2 years
Secondary outcomes (5)
Construct validity of SCQOLIT tool
Measure of psychometric property of SCQOLIT
Measured: 2 years
Responsiveness of SCQOLIT tool
Measure of psychometric property of SCQOLIT
Measured: 2 years
Differences in scores from baseline to follow-up
Measure of psychometric property of SCQOLIT - clinically important difference. A statistical analysis of the differences in scores will be calculated.
Measured: 2 years
Proportion of responses at the uppermost and lowermost end of the scale
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.
Measured: 2 years
Intra- and inter- participant change in scores
Measure of psychometric property of SCQOLIT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Rubeta Matin, Oxford University Hospitals NHS Trust
- Investigators
- Rubeta N Matin, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580916
- Sponsor's protocol ID
- 11054
- Acronym
- SCQOLIT
- Status last verified
- Dec 2020
- First submitted
- 25 Aug 2015
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) - a Feasibility Study in Non-melanoma Skin Cancer
- ClinicalTrials.gov ID
- NCT02580916
- Acronym / sponsor ID
- SCQOLIT / 11054
- Conditions
- Skin Neoplasm, Squamous Cell Carcinoma, Basal Cell Carcinoma
- Keywords
- non-melanoma skin cancer, outcome assessment, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- Jul 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Postal) | Experimental | Other: SCQOLIT questionnaireThese 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. |
| Group 2 (Clinic-based) | Experimental | Other: SCQOLIT questionnaireThese 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCQOLIT questionnaireParticipants 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) | Other | Group 1 (Postal), Group 2 (Clinic-based) |
Primary outcome
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.
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
5 secondary outcomes
Construct validity of SCQOLIT tool
Time frame: 2 years
Responsiveness of SCQOLIT tool
Time frame: 2 years
Differences in scores from baseline to follow-up
Time frame: 2 years
Proportion of responses at the uppermost and lowermost end of the scale
Time frame: 2 years
Intra- and inter- participant change in scores
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubeta N Matin principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCQOLIT questionnaire in people with Skin Neoplasm and Squamous Cell Carcinoma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCQOLIT questionnaire response rates (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.