Holistic Needs Assessments in Patients With Melanoma

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06189261
• Other study ID #: RE4090
• Status: Completed
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2023
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

no additional detail, study has ended

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

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.

Locations

Country	Name	City	State
United Kingdom	Monklands Hospital, NHS Lanarkshire	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)