Clinical trial NCT06189261: Holistic Needs Assessments in Patients With Melanoma
Official title: Feasibility and Acceptability of a Holistic Needs Assessment Intervention Employing Patient-reported Outcome Measures (PROMs) to Support Newly Diagnosed Patients With Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Unsatisfied Needs
Keywords: Supportive care
Unsatisfied needs
Melanoma
Holistic assessment
Patient-reported outcomes
PROMs
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: no additional detail, study has ended

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of intervention
timeFrame: Baseline to end of study, a total of 9 months
measure: Acceptability of intervention
timeFrame: Baseline to end of study, a total of 9 months
Secondary outcomes:
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)
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)
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)
measure: Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)
timeFrame: 1 month post-baseline (follow-up), 3 months post-baseline (follow-up
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)
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)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Monklands Hospital, NHS Lanarkshire
state: Lanarkshire
Study officials:
affiliation: University of Surrey
name: Roma Maguire, PhD
role: PRINCIPAL_INVESTIGATOR
References: