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临床试验/NCT06189261
NCT06189261已完成不适用

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

University of Surrey1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Acceptability of intervention

研究概览

简要总结

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.

详细描述

no additional detail, study has ended

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients not meeting the afore-mentioned criteria will be excluded.

结局指标

主要结局

Acceptability of intervention

时间窗: 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.

Feasibility of intervention

时间窗: 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.

次要结局

  • Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)(1 month post-baseline (follow-up), 3 months post-baseline (follow-up)
  • Quality of Life (Functional Assessment of Cancer Therapy - Melanoma (FACT-M)(Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up))
  • Edmonton Symptom Assessment System (ESAS)(Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up))
  • Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)(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)(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)(Baseline (first consultation), 3 months post-baseline (follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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