Clinical trial · Observational
Holistic Needs Assessments in Patients With Melanoma
Feasibility and Acceptability of a Holistic Needs Assessment Intervention Employing Patient-reported Outcome Measures (PROMs) to Support Newly Diagnosed Patients With Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Unsatisfied Needs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Holistic needs assessment based on the use of patient-reported outcome measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A diagnosis of malignant melanoma Stage I or II regardless of tumour thickness. * Within 1 month post-initial diagnosis following a MDT meeting. * Aged 18 years or over. * Deemed by a member of the MDT to be physically and psychologically fit to participate. * Able to read and write English. * Able to provide written informed consent. Exclusion Criteria: * Patients not meeting the afore-mentioned criteria will be excluded.
References
Publications (0)
Data not yet available