Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT06189261
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2016-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holistic Needs Assessments in Patients With Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2016-03-01', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of intervention', 'timeFrame': 'Baseline to end of study, a total of 9 months', 'description': 'Data on patient availability/recruitment, time and resource requirements, missing data, patient retention will be recorded and analysed.'}, {'measure': 'Acceptability of intervention', 'timeFrame': 'Baseline to end of study, a total of 9 months', 'description': 'Data on adherence to intervention, perceived burden, timing of intervention will be collected through interviews with participants and health professionals.'}], 'secondaryOutcomes': [{'measure': 'Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)', 'timeFrame': 'Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)', 'description': 'no additional detail, study completed'}, {'measure': 'Quality of Life (Functional Assessment of Cancer Therapy - Melanoma (FACT-M)', 'timeFrame': 'Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)', 'description': 'no additional detail, study completed'}, {'measure': 'Self-efficacy (Communication and Attitudinal Self-Efficacy scale - Cancer (CASE-Cancer)', 'timeFrame': 'Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)', 'description': 'no additional detail, study completed'}, {'measure': 'Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)', 'timeFrame': '1 month post-baseline (follow-up), 3 months post-baseline (follow-up', 'description': 'no additional detail, study completed'}, {'measure': 'Edmonton Symptom Assessment System (ESAS)', 'timeFrame': 'Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)', 'description': 'no additional detail, study completed'}, {'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) and EORTC Melanoma-38 (MEL-38)', 'timeFrame': 'Baseline (first consultation), 3 months post-baseline (follow-up)', 'description': 'no additional detail, study completed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supportive care', 'Unsatisfied needs', 'Melanoma', 'Holistic assessment', 'Patient-reported outcomes', 'PROMs'], 'conditions': ['Melanoma', 'Unsatisfied Needs']}, 'descriptionModule': {'briefSummary': "This study will assess whether a needs assessment/management intervention for patients with malignant melanoma is achievable, reasonable, realistic and of value to patients with malignant melanoma and health professionals involved in their care.\n\nThe study will also explore what the levels of patients' unmet needs are, whether unmet needs change over time, and what the potential effects of the intervention may be on patients' unmet needs, symptom severity, self-confidence in dealing with the illness, wellbeing, and satisfaction with the care received.\n\nIn this study, the investigators will involve skin cancer nurse specialists, who will be asked to use an 'intervention questionnaire' to offer a needs assessment/management intervention to 30 people newly diagnosed with malignant melanoma. The investigators have used information from the literature to select the most appropriate 'intervention questionnaire' for this patient population.\n\nEach consenting patient (i.e. participant) will be expected to participate in the study over 4 months. During the study, two intervention consultations will take place 1 and 3 months after the initial clinical team meeting, where each participant's case will be discussed. At the start of each intervention consultation, participants will be asked to complete the intervention questionnaire. The recorded information will be passed to their nurse specialist, who will identify the participant's needs and offer tailored advice and support to meet these needs.\n\nThroughout the study, participants will also be asked to complete a set of questionnaires in the clinic (months 1 and 3) or at home (months 2 and 4) to explore potential effects of the intervention. A study evaluation form will be used at month 4 to collect participants' and health professionals' views on the intervention and how it was delivered. Face-to-face interviews will take place at the end of the study to explore participants' (a subset of 10 people) and health professionals' experiences with the intervention.", 'detailedDescription': 'no additional detail, study has ended'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A convenience sample of up to 30 newly diagnosed patients with malignant melanoma will be recruited from out-patient clinics at one NHS board in Scotland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of malignant melanoma Stage I or II regardless of tumour thickness.\n* Within 1 month post-initial diagnosis following a MDT meeting.\n* Aged 18 years or over.\n* Deemed by a member of the MDT to be physically and psychologically fit to participate.\n* Able to read and write English.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients not meeting the afore-mentioned criteria will be excluded.'}, 'identificationModule': {'nctId': 'NCT06189261', 'briefTitle': 'Holistic Needs Assessments in Patients With Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': 'Feasibility and Acceptability of a Holistic Needs Assessment Intervention Employing Patient-reported Outcome Measures (PROMs) to Support Newly Diagnosed Patients With Malignant Melanoma', 'orgStudyIdInfo': {'id': 'RE4090'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with stage 1/2 malignant melanoma', 'description': "During the study, two intervention consultations will take place 1 and 3 months after the initial clinical team meeting, where each participant's case will be discussed. At the start of each intervention consultation, patients will be asked to complete the intervention questionnaire. The recorded information will be passed to their nurse specialist, who will identify the participant's needs and offer tailored advice and support to meet these needs. Throughout the study, participants will also be asked to complete a set of questionnaires in the clinic (months 1 and 3) or at home (months 2 and 4) to explore potential effects of the intervention.", 'interventionNames': ['Other: Holistic needs assessment based on the use of patient-reported outcome measures']}], 'interventions': [{'name': 'Holistic needs assessment based on the use of patient-reported outcome measures', 'type': 'OTHER', 'description': "During the study, two intervention consultations will take place 1 and 3 months after the initial clinical team meeting, where each participant's case will be discussed. At the start of each intervention consultation, participants will be asked to complete the intervention patient-reported outcome measure (i.e. Distress Thermometer and Problem Checklist, and Supportive Care Needs Survey-Melanoma Module). The recorded information will be passed to their nurse specialist, who will identify the participant's needs and offer tailored advice and support to meet these needs.", 'armGroupLabels': ['Patients with stage 1/2 malignant melanoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ML6 0JS', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'facility': 'Monklands Hospital, NHS Lanarkshire', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Roma Maguire, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Surrey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymised individual participant data (IPD) collected as part of this project will be used in publications and presentations following the end of the study. In addition, anonymised IPD will be shared with colleagues from the European Organisation for Research and Treatment of Cancer (EORTC) Melanoma research group to aid the psychometric development of the new Melanoma module of the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) questionnaire. Written patient consent will be sought before any data are shared with the above-mentioned group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}