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NCT04675346 Clinical Trial

Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors

Melanoma Stage III Clinical Trial

— EUNASS  

Official title:
Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04675346
Other study ID # 19/SC/0554
Secondary ID 261224
Status Completed
Phase
First received
Last updated
Start date November 18, 2020
Est. completion date September 30, 2022

Study information
Verified date November 2022
Source Oxford University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, multi-centred cohort study whereby the EUNASS Study questionnaire will be administered electronically to identify needs of melanoma survivors, the extent to which these needs are being met, and identify areas which have the greatest need for development. It will also evaluate behaviour in relation to sun protection and skin self-examination (SSE). It will be a self-completed questionnaire. Qualitative work using semi-structured interviews will explore the needs of melanoma survivors in greater depth, will present examples of potential interventions to improve SSE and explore factors that determine the likelihood of engaging in an intervention which can address unmet needs, such as improving SSE. Taken together, the data will provide the evidence base to inform the development of an intervention to improve SSE, which can subsequently be tested in secondary care services.

Recruitment information / eligibility
Status Completed
Enrollment 252
Est. completion date September 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years or above. - Histological diagnosis of primary cutaneous invasive melanoma (any Breslow thickness) at 3 - 12 months from diagnosis (as most primary treatment will be complete by 3 mths) - American Joint Cancer Committee Version 8 [2018] (AJCC V8) Stage I - III melanoma at time of recruitment - Able to complete an electronic questionnaire Exclusion Criteria: - Other current active internal malignancy (i.e. does not include non-melanoma skin cancers) - Inability to independently complete electronic questionnaire - AJCC V8 Stage IV melanoma at time of recruitment - Clinical stage of disease unknown / unconfirmed

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Questionnaire

Locations
Country Name City State
United Kingdom Churchill Hospital Headington Oxford

Sponsors (4)
Lead Sponsor Collaborator
Oxford University Hospitals NHS Trust Barts & The London NHS Trust, Ninewells Hospital, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mixed methods: analysis of a) Patient questionnaire responses and b) Semi-structured interviews Mixed methods analysis - quantitative and qualitative results 2 years
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