MelanomaNCT06189261
Holistic Needs Assessments in Patients With Melanoma
An observational study of Melanoma and Unsatisfied Needs, run by University of Surrey at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Unsatisfied Needs
- What is being tested?
- Holistic needs assessment based on the use of patient-reported outcome measures
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A convenience sample of up to 30 newly diagnosed patients with malignant melanoma will be recruited from out-patient clinics at one NHS board in Scotland.
Who may be able to join
- 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.
Who cannot join
- Patients not meeting the afore-mentioned criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Monklands Hospital, NHS Lanarkshire
Glasgow, Lanarkshire, ML6 0JS
About this study
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
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.
Read more
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.
Read the detailed description
no additional detail, study has ended
- Conditions
- Melanoma, Unsatisfied Needs
- Being tested
- Holistic needs assessment based on the use of patient-reported outcome measures
- Keywords
- Supportive care, Unsatisfied needs, Melanoma, Holistic assessment, Patient-reported outcomes, PROMs
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic needs assessment based on the use of patient-reported outcome measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Holistic needs assessment based on the use of patient-reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Data on patient availability/recruitment, time and resource requirements, missing data, patient retention will be recorded and analysed.
Measured: Baseline to end of study, a total of 9 months
Acceptability of intervention
Data on adherence to intervention, perceived burden, timing of intervention will be collected through interviews with participants and health professionals.
Measured: Baseline to end of study, a total of 9 months
Secondary outcomes (6)
Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)
no additional detail, study completed
Measured: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
Quality of Life (Functional Assessment of Cancer Therapy - Melanoma (FACT-M)
no additional detail, study completed
Measured: 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)
no additional detail, study completed
Measured: Baseline (first consultation), 1 month post-baseline (follow-up), 2 months post-baseline (second consultation), 3 months post-baseline (follow-up)
Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)
no additional detail, study completed
Measured: 1 month post-baseline (follow-up), 3 months post-baseline (follow-up
Edmonton Symptom Assessment System (ESAS)
no additional detail, study completed
Measured: 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)
no additional detail, study completed
Measured: Baseline (first consultation), 3 months post-baseline (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study startFeb 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roma Maguire, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189261
- Sponsor's protocol ID
- RE4090
- Status last verified
- Dec 2023
- First submitted
- 1 Mar 2016
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymised individual participant data (IPD) collected as part of this project will be used in publications and presentations following the end of the study. In addition, anonymised IPD will be shared with colleagues from the European Organisation for Research and Treatment of Cancer (EORTC) Melanoma research group to aid the psychometric development of the new Melanoma module of the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) questionnaire. Written patient consent will be sought before any data are shared with the above-mentioned group.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06189261
- Acronym / sponsor ID
- RE4090
- Conditions
- Melanoma, Unsatisfied Needs
- Keywords
- Supportive care, Unsatisfied needs, Melanoma, Holistic assessment, Patient-reported outcomes, PROMs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stage 1/2 malignant melanoma | – | Other: Holistic needs assessment based on the use of patient-reported outcome measuresDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of up to 30 newly diagnosed patients with malignant melanoma will be recruited from out-patient clinics at one NHS board in Scotland.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients not meeting the afore-mentioned criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holistic needs assessment based on the use of patient-reported outcome measuresDuring 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. | Other | Patients with stage 1/2 malignant melanoma |
Primary outcome
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.
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.
6 secondary outcomes
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)
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)
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)
Experiences of care (Patient Satisfaction with Cancer Care questionnaire (PSCC)
Time frame: 1 month post-baseline (follow-up), 3 months post-baseline (follow-up
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data (IPD) collected as part of this project will be used in publications and presentations following the end of the study. In addition, anonymised IPD will be shared with colleagues from the European Organisation for Research and Treatment of Cancer (EORTC) Melanoma research group to aid the psychometric development of the new Melanoma module of the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) questionnaire. Written patient consent will be sought before any data are shared with the above-mentioned group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roma Maguire, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Unsatisfied Needs, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: Baseline to end of study, a total of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.