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Trial registered on ANZCTR
Registration number
ACTRN12624001013550
Ethics application status
Approved
Date submitted
19/07/2024
Date registered
21/08/2024
Date last updated
21/08/2024
Date data sharing statement initially provided
21/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
My Hodgkin My Health: Feasibility of mobile application to collect health status following treatment for Hodgkin Lymphoma
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Scientific title
My Hodgkin My Health: Feasibility of mobile application to collect long term follow up data about Hodgkin Lymphoma patients.
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Secondary ID [1]
312436
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
MHMH Pilot
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma
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Condition category
Condition code
Cancer
330922
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0
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will receive access to the MyHodgkin MyHealth mobile app as they are enrolled on the study. The condition we are observing is Hodgkin Lymphoma and its side effects following treatment.
Participants will enter their Hodgkin Lymphoma treatment and response information, then complete a questionnaire on their current medical health including cardiac, respiratory, fertility, endocrine health. The Questionnaires may take 30-60 minutes and does not need to be complete in one session.
Updates are requested every 6 months during the overall duration of the study with is 5 years for the pilot.
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Intervention code [1]
328940
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Lifestyle
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Successful recruitment of greater than or equal to 30% of Australian Response-Adjusted Therapy for Advanced Hodgkin Lymphoma (RATHL) study participants
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Assessment method [1]
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Patient recruit of 30-40 RATHL participants after review of study record
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Timepoint [1]
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18 months from initial launch of the MHMH application.
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Secondary outcome [1]
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Participant retention
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Assessment method [1]
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Proportion of participants retained in the study at 12 months after review of questionnaire completion rate on the app.
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Timepoint [1]
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12 months from initial data entry point.
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Eligibility
Key inclusion criteria
1. Age equal or greater than 18 years
2. Participants must have received treatment for histologically confirmed classical HL according to the WHO classification
3. Sufficient digital and English literacy to complete the app-based questionnaire
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Being unable or unwilling to give informed consent
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Descriptive statistics will be used to analyse the primary and secondary outcomes. Ordinal and nominal measures will be reported as counts and percentages. Continuous data will be reported using mean and standard deviation or standard error where appropriate.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2024
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Actual
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Date of last participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last data collection
Anticipated
1/09/2029
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Sydney Local Health District
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Address [1]
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Country [1]
316854
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Australia
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Primary sponsor type
Government body
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Name
Sydney Local Health District
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319102
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Country [1]
319102
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District HREC – Concord Repatriation General Hospital
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Ethics committee address [1]
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http://www.slhd.nsw.gov.au/concord/ethics/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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10/05/2023
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Approval date [1]
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16/06/2023
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Ethics approval number [1]
315614
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Summary
Brief summary
This study aims to examine the feasibility of a mobile application to collect follow up health data about Hodgkin Lymphoma survivors. Who is it for? You may be eligible to participate in this study if you are a patient aged 18 years or over, and must have received treatment for histologically confirmed classical HL according to the WHO classification. Study details Participants will enter their Hodgkin treatment and lymphoma response information, then complete a quesitonnaire on their current medical health including cardiac, respiratory, fertility, endocrine health. It is hoped that the results of this trial will help improve the lives of HL survivors.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nicole Wong Doo
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Address
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Dept Haematology, Concord Hospital, Hospital Rd, Concord NSW 2139
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Country
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Australia
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Phone
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+61 297676662
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Georgia Klemm
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Address
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Concord Haematology Clinical Research Unit, Concord Repatriation General Hospital
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Country
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Australia
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Phone
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+61 29767 6858
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Georgia Klemm
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Address
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Concord Haematology Clinical Research Unit, Concord Repatriation General Hospital
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Country
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Australia
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Phone
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+61 29767 6858
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Fax
135260
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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