Trial Review

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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
Scientific title
My Hodgkin My Health: Feasibility of mobile application to collect long term follow up data about Hodgkin Lymphoma patients.
Secondary ID [1] 312436 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MHMH Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 334259 0
Condition category
Condition code
Cancer 330922 330922 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328940 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338688 0
Successful recruitment of greater than or equal to 30% of Australian Response-Adjusted Therapy for Advanced Hodgkin Lymphoma (RATHL) study participants
Timepoint [1] 338688 0
18 months from initial launch of the MHMH application.
Secondary outcome [1] 437030 0
Participant retention
Timepoint [1] 437030 0
12 months from initial data entry point.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Being unable or unwilling to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/09/2029
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316854 0
Government body
Name [1] 316854 0
Sydney Local Health District
Country [1] 316854 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319102 0
None
Name [1] 319102 0
Address [1] 319102 0
Country [1] 319102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315614 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 315614 0
Ethics committee country [1] 315614 0
Australia
Date submitted for ethics approval [1] 315614 0
10/05/2023
Approval date [1] 315614 0
16/06/2023
Ethics approval number [1] 315614 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135258 0
Dr Nicole Wong Doo
Address 135258 0
Dept Haematology, Concord Hospital, Hospital Rd, Concord NSW 2139
Country 135258 0
Australia
Phone 135258 0
+61 297676662
Fax 135258 0
Email 135258 0
nicole.wongdoo@health.nsw.gov.au
Contact person for public queries
Name 135259 0
Ms Georgia Klemm
Address 135259 0
Concord Haematology Clinical Research Unit, Concord Repatriation General Hospital
Country 135259 0
Australia
Phone 135259 0
+61 29767 6858
Fax 135259 0
Email 135259 0
slhd-concordhaematologyclinicalresearch@health.nsw.gov.au
Contact person for scientific queries
Name 135260 0
Ms Georgia Klemm
Address 135260 0
Concord Haematology Clinical Research Unit, Concord Repatriation General Hospital
Country 135260 0
Australia
Phone 135260 0
+61 29767 6858
Fax 135260 0
Email 135260 0
slhd-concordhaematologyclinicalresearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.