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OpenTrials
Completed

NCT Number: NCT06189261

Holistic Needs Assessments in Patients With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monklands Hospital, NHS Lanarkshire

Glasgow, Lanarkshire, ML6 0JS, United Kingdom

About this study

no additional detail, study has ended

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Feasibility of intervention

    Time frame: Baseline to end of study, a total of 9 months

    Data on patient availability/recruitment, time and resource requirements, missing data, patient retention will be recorded and analysed.

  2. Acceptability of intervention

    Time frame: Baseline to end of study, a total of 9 months

    Data on adherence to intervention, perceived burden, timing of intervention will be collected through interviews with participants and health professionals.

Secondary outcomes

  1. Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)

    Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)

    no additional detail, study completed

  2. Quality of Life (Functional Assessment of Cancer Therapy - Melanoma (FACT-M)

    Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)

    no additional detail, study completed

  3. Self-efficacy (Communication and Attitudinal Self-Efficacy scale - Cancer (CASE-Cancer)

    Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)

    no additional detail, study completed

  4. Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)

    Time frame: 1 month post-baseline (follow-up), 3 months post-baseline (follow-up

    no additional detail, study completed

  5. Edmonton Symptom Assessment System (ESAS)

    Time frame: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)

    no additional detail, study completed

  6. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) and EORTC Melanoma-38 (MEL-38)

    Time frame: Baseline (first consultation), 3 months post-baseline (follow-up)

    no additional detail, study completed

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Registry information

Official study title

Feasibility and Acceptability of a Holistic Needs Assessment Intervention Employing Patient-reported Outcome Measures (PROMs) to Support Newly Diagnosed Patients With Malignant Melanoma

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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