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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma Stage III; Melanoma, Stage II; Melanoma, Stage I
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LE
      • Churchill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Dermatology or Medical Oncology departments with a confirmed diagnosis of AJCC V8 stage I - III melanoma in the last year

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Questionnaire; The EUNASS Study Questionnaire is an electronic questionnaire (using the Qualtrics programme) designed to assess management after diagnosis of melanoma and during follow-up, health status, fear of melanoma recurrence, melanoma-specific supportive care needs, sun protection behaviour, views and habits about SSE and standard socio-demographic details.	Other: Questionnaire; Questionnaire
Interviews; A qualitative researcher will undertake 25-30 semi-structured interviews with participants who have volunteered their contact details in the final section of the EUNASS Study Questionnaire. A purposive sampling approach will be taken for participant recruitment to this part of the study.	Other: Questionnaire; Questionnaire

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Collaborators: University of Oxford; Barts & The London NHS Trust; Ninewells Hospital
• Investigators: Principal Investigator: Rubeta Matin, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 19/SC/0554; 261224 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No