Holistic Needs Assessments in Patients With Melanoma

NCT ID: NCT06189261

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

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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

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no additional detail, study has ended

Conditions

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Melanoma Unsatisfied Needs

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Holistic needs assessment based on the use of patient-reported outcome measures

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roma Maguire, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Locations

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Monklands Hospital, NHS Lanarkshire

Glasgow, Lanarkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RE4090

Identifier Type: -

Identifier Source: org_study_id

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