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Trial registered on ANZCTR


Registration number
ACTRN12620000902998
Ethics application status
Approved
Date submitted
22/05/2020
Date registered
14/09/2020
Date last updated
14/09/2020
Date data sharing statement initially provided
14/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the Impact of an Online Intervention Testicular Cancer on Men with Newly Diagnosed Testicular Cancer (TrueNTH TC)
Scientific title
'Assessing the Impact of an Online Intervention TrueNTH TC on levels of distress in Men with Newly Diagnosed Testicular Cancer
Secondary ID [1] 300272 0
Not applicable
Universal Trial Number (UTN)
Not applicable
Trial acronym
TrueNTH TC
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Testicular cancer 315850 0
Condition category
Condition code
Cancer 314132 314132 0 0
Testicular

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TrueNTH TC, an online intervention designed to provide testicular cancer (TC) related information and peer support. The information and resources provided on the intervention website have been designed specifically for this study. Participants will have access to TrueNTH TC content for 4 weeks after initial login. Their tc-trial.org login will cease to function 4 weeks after initial login.

Patients will be randomised using an electronic randomisation tool at the coordinating site into the following arms in a 1:1 ratio:

1) Arm 1: Early Intervention Arm
Following consent to the study,
- The participant will undergo baseline assessment of distress using distress thermometer (DT) and Hospital Anxiety and Depression Scale (HADS) with the Study Coordinator via a telephone interview. The study coordinator will also conduct a baseline demographic questionnaire over the phone at this time.
- Participants will be provided with a unique URL to the study website immediately. The website can be accessed anywhere, on their mobile phone or at home on their PC or laptop.The website contains 3 main elements: (1) Information and resources about TC, (2) A peer support platform that allows men who are currently experiencing a diagnosis or treatment for TC to be offered advice by a long term TC survivor and (3) Frequently asked questions regarding TC (responses are from both clinicians and men who have lived the experience). Participants can choose whether or not they use the peer support platform to communicate with another man who is a long term TC survivor. If the participant does choose to use the peer support platform the study does not set the length of time or numbers of occasions that contact is made, this is up to the participant.
A pool of unique URLs will be provided to the Study Coordinator prior to the commencement of the trial. This allows for coded data to be collected during the study with re-identification only possible by backward decoding of the unique URL at the study site. Each URL will contain an ID used to track the interactions of each participant throughout their on-line sessions. The ID contains no personal or patient specific data.
-Participants will undergo the following assessments via the study website:
1. Modified DT via the TrueNTH TC website at time of initial login
2. Modified DT at time of leaving the website when total cumulative use of the website has reached 10 minutes. These will be completed by the participant through the provision of a unique link.
- The participant will undergo assessment of distress using distress thermometer (DT) and Hospital Anxiety and Depression Scale (HADS) with the Study Coordinator via a telephone interview at the specified time points (2 times within a month of initial use of TrueNTH TC).

2) Arm 2: Delayed intervention arm
- Participants will undergo baseline assessments of distress using DT and HADS twice, at study enrolment and one week later through a telephone interview with the study coordinator. The study coordinator will also conduct a baseline demographic questionnaire over the phone at the time of enrolment.
- 1 week post enrolment, the participant will be provided with a unique URL to the study website. The website can be accessed anywhere, on their mobile phone or at home on their PC or laptop.The website contains 3 main elements: (1) Information and resources about TC, (2) A peer support platform that allows men who are currently experiencing a diagnosis or treatment for TC to be offered advice by a long term TC survivor and (3) Frequently asked questions regarding TC (responses are from both clinicians and men who have lived the experience). Participants can choose whether or not they use the peer support platform to communicate with another man who is a long term TC survivor. If participants do choose to use the peer support platform the study does not set the length of time or numbers of occasions that contact is made, this is up to the participant.
A pool of unique URLs will be provided to the Study Coordinator prior to the commencement of the trial. This allows for coded data to be collected during the study with re-identification only possible by backward decoding of the unique URL at the study site. Each URL will contain an ID used to track the interactions of each participant throughout their on-line sessions. The ID contains no personal or patient specific data.
-Participants will undergo the following assessments via the study website:
1. Modified DT via the TrueNTH TC website at time of initial login
2. Modified DT at time of leaving the website when total cumulative use of the website has reached 10 minutes. These will be completed by the participant through the provision of a unique link.
- The Study Coordinator conducts DT and HADS assessment at the specified time points (2 more times within 1.5 months).
Intervention code [1] 316547 0
Prevention
Comparator / control treatment
Participants in the delayed intervention arm will receive standard care i.e. scheduled oncology appointments only, during the first week (as per the treating hospital's practice) before being given access to the study site URL one week post-enrolment.
Control group
Active

Outcomes
Primary outcome [1] 322520 0
Short term change in levels of distress in patients with newly diagnosed TC comparing:
1) patients who have access to TrueNTH TC to
2)patients who do not have access to TrueNTH TC.
This will be measured using Distress Thermometer (DT) conducted over the phone and Modified Distress Thermometer (mDT) conducted via the TrueNTH TC website.
Timepoint [1] 322520 0
Early Intervention Arm:
-Baseline immediately after consent (DT).
- Time of initial login to TrueNTH TC website (mDT).
- After 10mins of cumulative use of TrueNTH TC website (mDT).
- Day 8 (+/-5) post enrolment (DT).
- Day 29 (+/-5) post enrolment (DT).
Delayed Intervention Arm:
-Baseline immediately after consent (DT)
- Day 8 (+/-5) post enrolment (DT).
- Time of initial login to TrueNTH TC website (mDT).
- After 10mins of cumulative use of TrueNTH TC website (mDT).
- Day 15 (+/-5) post enrolment (DT)
- Day 36 (+/-5) post enrolment (DT)
Secondary outcome [1] 383602 0
Characterise the natural course of levels of distress in men over a 1 week period shortly after TC diagnosis.
Distress evaluated using Distress Thermometer.
Timepoint [1] 383602 0
Delayed Intervention Arm - Baseline (immediately after consent) and at Day 8 post enrolment
Secondary outcome [2] 385758 0
Characterise the natural course of levels of anxiety in men over a 1 week period shortly after TC diagnosis.
Anxiety assessed using Hospital Anxiety and Depression Scale Anxiety score.

Timepoint [2] 385758 0
Delayed Intervention Arm - Baseline (immediately after consent) and at Day 8 post enrolment
Secondary outcome [3] 385761 0
Characterise the natural course of levels of depression in men over a 1 week period shortly after TC diagnosis.
Depression assessed using Hospital Anxiety and Depression Scale Depression score.
Timepoint [3] 385761 0
Delayed Intervention Arm - Baseline (immediately after consent) and at Day 8 post enrolment

Eligibility
Key inclusion criteria
• Men with newly diagnosed TC (within 4 weeks of patient becoming aware of TC diagnosis)
• Consistent access to a computer/smart phone and internet
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Men who are not proficient in reading and writing English are excluded from participating. Proficiency in English is defined as at least year 7 level of English education.
• Age < 18 years old. It has been found that children and adolescents under the age of 18 affected by testicular cancer face different issues (e.g. disruption to school) to affected adults.
• Significant cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary objective of this study is to compare the DT score at 1 week post randomisation between participants assigned to the early and delayed intervention arms. This will be done by fitting an analysis of covariance (ANCOVA) model with treatment arm and baseline DT score and week 1 DT score as outcome variable. The same analysis will be done to answer the secondary outcomes with anxiety and depression as the outcome variables, with
adjustment for baseline anxiety and depression scores.
The levels of distress, anxiety and depression in men newly diagnosed with TC will be
summarised at baseline using means and 95% confidence intervals of the means, both per
treatment arm and for all patients combined. The levels will also be summarised using means and 95% confidence intervals of the means at the relevant time points of assessment in each treatment arm.
Three linear regression model will be fitted at baseline in all patients, with levels of distress, anxiety and depression, respectively as outcome variables to determine which of the baseline characteristics were associated with distress, anxiety and depression, and how distress, anxiety and/or depression might be associated with adherence to surveillance protocols. Data regarding baseline characteristics and adherence to surveillance protocols are routinely collected into an existing testicular cancer registry at each participating site.

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)
VIC
Recruitment hospital [1] 16746 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 16747 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 16748 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 30356 0
3050 - Parkville
Recruitment postcode(s) [2] 30357 0
3065 - Fitzroy
Recruitment postcode(s) [3] 30358 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 304694 0
Charities/Societies/Foundations
Name [1] 304694 0
Movember Foundation
Address [1] 304694 0
Movember
PO Box 60
East Melbourne
VIC 3002 Australia
Country [1] 304694 0
Australia
Primary sponsor type
Other
Name
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Address
1G Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 305006 0
None
Name [1] 305006 0
Address [1] 305006 0
Country [1] 305006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305114 0
Melbourne Health HREC
Ethics committee address [1] 305114 0
Melbourne Health
Office for Research
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 305114 0
Australia
Date submitted for ethics approval [1] 305114 0
Approval date [1] 305114 0
06/12/2018
Ethics approval number [1] 305114 0

Summary
Brief summary
Assessing the Impact of an Online Intervention (TrueNTH Testicular Cancer) on Men with Newly Diagnosed Testicular Cancer.

Who is it for?

If you are an adult male who has been diagnosed with testicular cancer in the last 4 weeks, and you have regular access to the internet on your home computer or smartphone you may eligible to participate in this study.

Study details

Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have immediate access to TrueNTH TC, an online intervention with testicular cancer-related information and peer support, and will have access for 4 weeks after initial login. Participants in the other group will have 'delayed' access to the intervention one week after study enrolment and will have access for 4 weeks after initial login.

Throughout the four week study period, participants will be asked to complete the stress questionnaires at set timepoints, either online through the TrueNTH TC website or during a telephone interview.

It is hoped that access to the TrueNTH TC website will reduce the stress and anxiety levels of newly diagnosed testicular cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99314 0
Dr Ben Tran
Address 99314 0
The Walter and Eliza Hall Institute of Medical Research (WEHI)
1G Royal Parade, Parkville, VIC 3052
Country 99314 0
Australia
Phone 99314 0
+61393452555
Fax 99314 0
Email 99314 0
ben.tran@petermac.org
Contact person for public queries
Name 99315 0
Ms Maria Edmonds
Address 99315 0
The Walter and Eliza Hall Institute of Medical Research (WEHI)
1G Royal Parade, Parkville, VIC 3052
Country 99315 0
Australia
Phone 99315 0
+61 3 9345 2555
Fax 99315 0
Email 99315 0
maria.edmonds@mh.org.au
Contact person for scientific queries
Name 99316 0
Dr Ben Tran
Address 99316 0
The Walter and Eliza Hall Institute of Medical Research (WEHI)
1G Royal Parade, Parkville, VIC 3052
Country 99316 0
Australia
Phone 99316 0
+61 3 9345 2555
Fax 99316 0
Email 99316 0
ben.tran@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The primary aim of the study is to evaluate short-term change in levels of distress among patients with newly diagnosed TC who have access to TrueNTH TC compared with patients who do not have access to TrueNTH TC. Therefore, aggregated reports will be more useful rather than individual reports.
What supporting documents are/will be available?
No other documents available
Summary results
No Results