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Trial registered on ANZCTR


Registration number
ACTRN12620001277932
Ethics application status
Approved
Date submitted
7/09/2020
Date registered
26/11/2020
Date last updated
26/11/2020
Date data sharing statement initially provided
26/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supportive Care Needs in Melanoma Patients and their Carers
Scientific title
Supportive Care Needs in Australian Melanoma Patients and Carers
Secondary ID [1] 302252 0
None
Universal Trial Number (UTN)
None
Trial acronym
SCN (Supportive Care Needs)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 318971 0
Condition category
Condition code
Cancer 316937 316937 0 0
Malignant melanoma
Mental Health 316938 316938 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For this observational study, we are interested to examine the supportive care needs that are experienced by melanoma patients and caregivers. We would like to find out whether these needs differ according to stage of disease or place of residence. We would also like to find out correlates of patients' and caregivers' supportive care needs, understand the patients' and carers' preferences for having these needs addressed and ascertain whether all needs are covered in validated questionnaires.

1. Patients and caregivers will be required to complete an online questionnaire that will take approximately 35 minutes of their time. Due to the online nature of data collection, the participants can choose whether to complete all the questions in one session, or over multiple sessions (by saving the form and returning to it later). The questionnaires will be self-report, and hosted on REDCap, online questionnaire administration platform. The patient questionnaire will consist of (1) demographic questions (gender, age, family status, education level, place of residence, income level, time since diagnosis (2) clinical information: melanoma stage, previous melanoma treatment, current melanoma treatment, current disease status, (3) validated questionnaires: Supportive Care Needs Survey - Short Form 34, Supportive Care Needs Survey melanoma module, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3, Melanoma Concerns Questionnaire, Depression, Anxiety and Stress Scale Short Form (4) service utilisation (past and current) questions that have been developed for this study. Caregivers' questionnaire will consist of: (1) demographic information (gender, age, family status, relationship to patient, education, place of residence, income level, time since the person they care for got diagnosed with melanoma (2) clinical information about the patient they care for (stage of melanoma, previous and current treatment, disease status) and (3) validated questionnaires (Supportive Care Needs Survey - Partners and carers, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3, Depression, Anxiety and Stress scales short form (4) service utilisation (past and current) questions that have been developed for this study.

2. The participants will self-select to participate in the interview. All participants will have an opportunity to provide their contact details (email) if they wish to participate in an interview. We will monitor the interview interest to ensure that the variety of disease stages are represented in the interviewed sample.

3. The interview session will be conducted separately from the online questionnaires. It will be organised and conducted by a research assistant, with training in qualitative interview administration and will be supervised by the Principal Investigator.
Intervention code [1] 318538 0
Not applicable
Comparator / control treatment
No control group as observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325040 0
PATIENTS:
Supportive care needs as assessed by:
- Supportive Care Needs Survey Short Form and Melanoma Module (analysed for all patient participants)
- Qualitative themes derived from interview responses of a subset of participants that self-select to participate in the interviews
Timepoint [1] 325040 0
At the time of questionnaire and interview completion
Primary outcome [2] 325363 0
CAREGIVERS:
Supportive care needs as assessed by:
- Supportive Care Needs Study Partners and Caregivers (analysed for all caregiver participants)
- Qualitative themes derived from interview responses of a subset of participants that self-select to participate in the interviews
Timepoint [2] 325363 0
At the time of questionnaire and interview completion
Secondary outcome [1] 386639 0
PATIENTS:
Preferences for addressing the supportive care needs - assessed by (1) the responses to the services utilisation questions (administered to all patients as a part of quantitative questionnaire) and (2) qualitative themes derived from semi-structured interviews administered to a subgroup of patients that self-select to participate in this study.
Timepoint [1] 386639 0
At the time of questionnaire and interview completion
Secondary outcome [2] 387650 0
CAREGIVERS:
Preferences for addressing the supportive care needs - assessed by (1) the responses to the services utilisation questions (administered to all caregivers as a part of quantitative questionnaire) and (2) qualitative themes derived from semi-structured interviews administered to a subgroup of caregivers that self-select to participate in this study.
Timepoint [2] 387650 0
At the time of questionnaire and interview completion

Eligibility
Key inclusion criteria
PATIENTS:
Sufficient English and cognitive ability to understand and respond to Participant Information Statement and study materials

Diagnosis of melanoma (stage I-IV)

Currently receiving melanoma treatment (e.g. surgery, immunotherapy, targeted therapy, radiation therapy or chemotherapy) OR Melanoma treatment (e.g. surgery, immunotherapy, targeted therapy, radiation therapy or chemotherapy) completed no longer than 2 years ago

CARERS:
Sufficient English and cognitive ability to understand and respond to Participant Information Statement and study materials

Self-identified as a carer to a person diagnosed with melanoma (stage I-IV) is currently undergoing treatment for their melanoma (e.g. surgery, immunotherapy, targeted therapy, radiation therapy or chemotherapy) OR Self-identified as a carer to a person diagnosed with melanoma (stage I-IV) has completed treatment for their melanoma (e.g. surgery, immunotherapy, targeted therapy, radiation therapy or chemotherapy) within the last 2 years

Relation could be, but is not limited to significant other (wife, husband, partner etc.), family (mother, father, son, daughter, sibling etc), friend. Relationship is defined by providing informal physical, emotional and / or instrumental support to the person with melanoma.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PATIENTS:
Under 18 years of age
Diagnosis of cancer other than melanoma in the last 5 years
Completed all melanoma treatments (e.g. surgery, immunotherapy, targeted therapy, radiation therapy or chemotherapy) more than 2 years ago

CARERS:
Under 18 years of age
People providing formal / professional support (e.g. community nurses, doctors, allied health team etc)
Self-identified as a carer to a person diagnosed with melanoma who has completed their treatment for melanoma (e.g. surgery, immunotherapy, targeted therapy, radiation therapy or chemotherapy) more than 2 years ago

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To have an adequate power for this study (80%) to detect a significant (p<0.05) small-moderate effect of stage of disease on supportive care needs, this study needs 160 participants (40 participants per stage of diagnosis). To account for missing and incomplete data, approximately 200 participants will be recruited for the quantitative part of the study. This further allows for the recruitment of participants for the qualitative part of the study, assuming one-fifth agrees to participate. Additionally, we aim to recruit 50 caregivers that will be matched with corresponding patients.
For the qualitative part of the study, we aim to recruit participants (patients/caregivers) until data saturation is achieved. Although it is difficult to define the required number a-priori, in most psycho-social research this occurs after approximately 10-15 interviews. Hence, we will aim to recruit 10-15 patients per stage (I-IV) and 10-15 caregivers.
To answer the main hypotheses questions, we will conduct analyses that include measures of central tendency, ANCOVA and binary logistic regression. To investigate whether patients’ and caregivers’ needs are inter-related, actor-patient interaction model will be used, which typically includes Structural Equation Modelling..
All quantitative analyses will be conducted in SPSS/AMOS.
Qualitative interviews will be transcribed verbatim and common themes analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 17451 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment hospital [2] 17452 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 31179 0
2060 - North Sydney
Recruitment postcode(s) [2] 31180 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 306673 0
Charities/Societies/Foundations
Name [1] 306673 0
Melanoma Institute Australia
Address [1] 306673 0
40 Rocklands Road
Wollstonecraft NSW 2067
Country [1] 306673 0
Australia
Funding source category [2] 306674 0
Charities/Societies/Foundations
Name [2] 306674 0
The Bill and Patricia Ritchie Foundation
Address [2] 306674 0
77 Dunning Avenue
2018 Sydney NSW
Country [2] 306674 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Melanoma Institute Australia
Address
40 Rocklands Road
Wollstonecraft NSW 2067
Country
Australia
Secondary sponsor category [1] 307225 0
None
Name [1] 307225 0
Address [1] 307225 0
Country [1] 307225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306853 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306853 0
Level 3
Administration Building (F23)
University of Sydney, NSW 2006
.
Ethics committee country [1] 306853 0
Australia
Date submitted for ethics approval [1] 306853 0
02/12/2019
Approval date [1] 306853 0
13/02/2020
Ethics approval number [1] 306853 0
2020/028

Summary
Brief summary
This observational study aims to investigate the supportive care needs of melanoma patients across different stages of the disease, as well as their caregivers.

Who is it for?
Patients- You may be eligible for this study if you are aged 18 years or older, have been diagnosed with melanoma (Stage I-IV), and are either currently undergoing treatment (including chemotherapy, immunotherapy, targeted therapy. radiation therapy or surgery), or have completed treatment within the last two years.
Carers- You may be eligible for this study if you are aged 18 years or older, and you are carer to a person diagnosed with melanoma (stage I-IV) who is currently undergoing treatment for their melanoma, or you are a carer to a person diagnosed with melanoma (stage I-IV) who has completed treatment for their melanoma within the last 2 years.

Study details
All participants (patients and carers) enrolled in this observational study will be asked to complete an online questionnaires asking them about their supportive care needs. It is anticipated that completion of the questionnaires will take about 35 minutes. Following this questionnaire, you will have an opportunity to provide your contact details to be contacted to participate in a semi-structured one-on-one interview with a member of the research team to further discuss their supportive care needs and preferences for future care. It is anticipated that the interview will take 30-60 minutes to complete.

It is hoped this research will provide further information regarding areas of concern for melanoma patients and their carers, and that these details will help clinicians to design and provide more useful support systems for melanoma patients in the future.
Trial website
Trial related presentations / publications
Public notes
Due to COVID-19 considerations, we will limit interviews to telephone and videoconferencing only. Interviews will take approximately 30-60 minutes to complete.

Contacts
Principal investigator
Name 105238 0
Dr Iris Bartula
Address 105238 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road, Wollstonecraft NSW 2065
Country 105238 0
Australia
Phone 105238 0
+61 2 9911 7398
Fax 105238 0
Email 105238 0
iris.bartula@melanoma.org.au
Contact person for public queries
Name 105239 0
Dr Iris Bartula
Address 105239 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road, Wollstonecraft NSW 2065
Country 105239 0
Australia
Phone 105239 0
+61 2 9911 7398
Fax 105239 0
Email 105239 0
iris.bartula@melanoma.org.au
Contact person for scientific queries
Name 105240 0
Dr Iris Bartula
Address 105240 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road, Wollstonecraft NSW 2065
Country 105240 0
Australia
Phone 105240 0
+61 2 9911 7398
Fax 105240 0
Email 105240 0
iris.bartula@melanoma.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an observational study and the way the Participant Information Statement is written at present, the consent is not obtained for data sharing.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
Other
'Other' documents specified
Data Dictionary
How or where can supporting documents be obtained?
Type [1] 9081 0
Study protocol
Citation [1] 9081 0
Link [1] 9081 0
Email [1] 9081 0
iris.bartula@melanoma.org.au
Other [1] 9081 0
Attachment [1] 9081 0
Type [2] 9082 0
Statistical analysis plan
Citation [2] 9082 0
Link [2] 9082 0
Email [2] 9082 0
iris.bartula@melanoma.org.au
Other [2] 9082 0
Attachment [2] 9082 0
Type [3] 9083 0
Ethical approval
Citation [3] 9083 0
Link [3] 9083 0
Email [3] 9083 0
iris.bartula@melanoma.org.au
Other [3] 9083 0
Attachment [3] 9083 0
Type [4] 9085 0
Other
Citation [4] 9085 0
Link [4] 9085 0
Email [4] 9085 0
iris.bartula@melanoma.org.au
Other [4] 9085 0
Attachment [4] 9085 0
Summary results
No Results