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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Unsatisfied Needs
• Intervention / Treatment: Other: Holistic needs assessment based on the use of patient-reported outcome measures

Detailed Description

no additional detail, study has ended

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, ML6 0JS
      • Monklands Hospital, NHS Lanarkshire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with stage 1/2 malignant melanoma; 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.

Other: Holistic needs assessment based on the use of patient-reported outcome measures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention	Data on patient availability/recruitment, time and resource requirements, missing data, patient retention will be recorded and analysed.	Baseline to end of study, a total of 9 months
Acceptability of intervention	Data on adherence to intervention, perceived burden, timing of intervention will be collected through interviews with participants and health professionals.	Baseline to end of study, a total of 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)	no additional detail, study completed	Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
Quality of Life (Functional Assessment of Cancer Therapy - Melanoma (FACT-M)	no additional detail, study completed	Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
Self-efficacy (Communication and Attitudinal Self-Efficacy scale - Cancer (CASE-Cancer)	no additional detail, study completed	Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)	no additional detail, study completed	1 month post-baseline (follow-up), 3 months post-baseline (follow-up
Edmonton Symptom Assessment System (ESAS)	no additional detail, study completed	Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) and EORTC Melanoma-38 (MEL-38)	no additional detail, study completed	Baseline (first consultation), 3 months post-baseline (follow-up)

Collaborators and Investigators

• Sponsor: University of Surrey
• Investigators: Principal Investigator: Roma Maguire, PhD, University of Surrey

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Melanoma; Patient-reported outcomes; Supportive care; PROMs; Unsatisfied needs; Holistic assessment
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: RE4090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.