Holistic Needs Assessments in Patients With Melanoma
- Conditions
- Unsatisfied NeedsMelanoma
- Interventions
- Other: Holistic needs assessment based on the use of patient-reported outcome measures
- Registration Number
- NCT06189261
- Lead Sponsor
- University of Surrey
- Brief 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.
- Detailed Description
no additional detail, study has ended
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- Patients not meeting the afore-mentioned criteria will be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with stage 1/2 malignant melanoma 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, 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.
- Primary Outcome Measures
Name Time Method Acceptability of intervention 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 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.
- Secondary Outcome Measures
Name Time Method Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC) 1 month post-baseline (follow-up), 3 months post-baseline (follow-up no additional detail, study completed
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) no additional detail, study completed
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) no additional detail, study completed
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) no additional detail, study completed
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) no additional detail, study completed
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) no additional detail, study completed
Trial Locations
- Locations (1)
Monklands Hospital, NHS Lanarkshire
🇬🇧Glasgow, Lanarkshire, United Kingdom