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Trial record 2 of 12 for:    MATINS

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

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ClinicalTrials.gov Identifier: NCT04675346
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborators:
Barts & The London NHS Trust
Ninewells Hospital
University of Oxford
Information provided by (Responsible Party):
Rubeta Matin, 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.


Condition or disease Intervention/treatment
Melanoma, Stage I Melanoma Stage III Melanoma, Stage II Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : November 17, 2021
Estimated Study Completion Date : November 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675346


Contacts
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Contact: Melanie Westmoreland 01865 228252 melanie.westmoreland@ouh.nhs.uk
Contact: Rubeta Matin, FRCP rubeta.matin@ouh.nhs.uk

Locations
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United Kingdom
Churchill Hospital Recruiting
Headington, Oxford, United Kingdom, OX3 7LE
Contact: Rubeta N Matin, PhD FRCP         
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Barts & The London NHS Trust
Ninewells Hospital
University of Oxford
Investigators
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Principal Investigator: Rubeta Matin Oxford University Hospitals NHS Trust
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Responsible Party: Rubeta Matin, Primary Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04675346    
Other Study ID Numbers: 19/SC/0554
261224 ( Other Identifier: IRAS )
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas