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Completed

NCT Number: NCT04675346

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

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.

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Key information

Conditions

Melanoma, Stage I Melanoma Melanoma Stage III Melanoma, Stage II Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaire

Primary outcomes

  1. Mixed methods: analysis of a) Patient questionnaire responses and b) Semi-structured interviews

    Time frame: 2 years

    Mixed methods analysis - quantitative and qualitative results

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Collaborators

  • Barts & The London NHS Trust
  • Ninewells Hospital
  • University of Oxford

Registry information

Acronym: EUNASS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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