Monklands Hospital, NHS Lanarkshire
Glasgow, Lanarkshire, ML6 0JS, United Kingdom
NCT Number: NCT06189261
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.
The 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.
In 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.
Each 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.
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. 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.
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Notify Me18 year and older
All sexes
Observational
Glasgow, Lanarkshire, ML6 0JS, United Kingdom
no additional detail, study has ended
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline to end of study, a total of 9 months
Data on patient availability/recruitment, time and resource requirements, missing data, patient retention will be recorded and analysed.
Time frame: Baseline to end of study, a total of 9 months
Data on adherence to intervention, perceived burden, timing of intervention will be collected through interviews with participants and health professionals.
Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
no additional detail, study completed
Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
no additional detail, study completed
Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
no additional detail, study completed
Time frame: 1 month post-baseline (follow-up), 3 months post-baseline (follow-up
no additional detail, study completed
Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
no additional detail, study completed
Time frame: Baseline (first consultation), 3 months post-baseline (follow-up)
no additional detail, study completed
University of Surrey
Other
Feasibility and Acceptability of a Holistic Needs Assessment Intervention Employing Patient-reported Outcome Measures (PROMs) to Support Newly Diagnosed Patients With Malignant Melanoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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