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

NCT04675346 | Completed

• 2 other identifiers: 19/SC/0554261224
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma, Stage I; Melanoma Stage III; Melanoma, Stage II

Outcome Measures

Primary Outcomes (1)

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

  Mixed methods analysis - quantitative and qualitative results

  2 years

Study Arms (2)

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

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

Interventions

Questionnaire OTHER

Questionnaire

Interviews; Questionnaire

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Barts & The London NHS Trust: collaborator
• Ninewells Hospital: collaborator
• University of Oxford: collaborator

Study Sites (1)

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rubeta Matin

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: November 18, 2020
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)