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

Completed

• Conditions: Melanoma Stage III; Melanoma, Stage II; Melanoma, Stage I
• Interventions: Other: Questionnaire

• Registration Number: NCT04675346
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Primary Completion: 2022-03-31
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-19
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interviews	Questionnaire	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.
Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Mixed methods: analysis of a) Patient questionnaire responses and b) Semi-structured interviews	2 years	Mixed methods analysis - quantitative and qualitative results

Trial Locations

Locations (1)

Churchill Hospital; 🇬🇧 Headington, Oxford, United Kingdom