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Trial registered on ANZCTR
Registration number
ACTRN12614000111673
Ethics application status
Not yet submitted
Date submitted
22/01/2014
Date registered
29/01/2014
Date last updated
29/01/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
e-TC: Getting back on track after testicular cancer – A feasibility study of an online intervention to reduce anxiety and depression in survivors of testicular cancer
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Scientific title
e:TC: Getting back on track after testicular cancer. A Pilot Study of the feasibility and acceptability of an online intervention for survivors of testicular cancer
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Secondary ID [1]
283958
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
e-TC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
mental health
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testicular cancer
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Condition category
Condition code
Cancer
291329
291329
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0
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Testicular
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Mental Health
291371
291371
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0
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Depression
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Mental Health
291372
291372
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
online intervention to address the specific unmet needs of TC survivors (such as for help with fear of cancer recurrence, body image and sexual issues, financial issues and re-establishing a sense of normal), as well as general anxiety and depression. Participants will be asked to complete 6 online modules over 10 weeks. Modules are self-directed but take approximately 1 hour to completeParticipants will also complete online questionnaires at baseline, after module 3 and after module 6. Completion/adherence will be tracked via online monitoring.
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Intervention code [1]
288645
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Behaviour
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Intervention code [2]
288666
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Treatment: Other
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Comparator / control treatment
uncontrolled intervention
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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acceptability - measured using qualitative assessments of participant comments entered as free text on the website for each module
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Assessment method [1]
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Timepoint [1]
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10 weeks
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Primary outcome [2]
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feasibility - measured using qualitative assessments of participant comments entered as free text on the website for each module
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Assessment method [2]
291348
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Timepoint [2]
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10 weeks
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Primary outcome [3]
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utility - measured using qualitative assessments of participant comments entered as free text on the website for each module
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Assessment method [3]
291349
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Timepoint [3]
291349
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10 weeks
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Secondary outcome [1]
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fear of cancer recurrence -using the the Fear of Recurrence Scale (FRS)
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Assessment method [1]
306500
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Timepoint [1]
306500
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10 weeks
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Secondary outcome [2]
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psychological distress - using the Hospital and Anxiety and Depression Scale (HADs)
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Assessment method [2]
306563
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Timepoint [2]
306563
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10 weeks
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Secondary outcome [3]
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unmet supportive care need - using the Unmet Supportive Care Needs Survey (SCNS)
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Assessment method [3]
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Timepoint [3]
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10 weeks
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Eligibility
Key inclusion criteria
Participants with a previous diagnosis of testicular cancer who:
1. >6 months and <5 years post-treatment
2. no evidence of recurrence
3. adequate English Language skills
4. aged over 18 years
5. access to a computer at least weekly for up to ten weeks
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Men who completed treatment less than 6 months ago
2. Men experiencing recurrent disease
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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)
Participants will be briefed about the study by their oncologist either at a followup
appointment or by mail. The oncologist will seek verbal consent to forward the men’s contact details to the research team. The research coordinator will contact the men by phone to explain what is involved in participation and send an email to prospective participants with the web address of eTC.
The study and the intervention are further explained on the website and men are invited to download the participant information form and indicate their consent online before creating a personal profile and login.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
non randomised
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
pre-post analysis of measures, qualitative analysis of free text items
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/01/2014
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Actual
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Date of last participant enrolment
Anticipated
31/08/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
1986
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Peter MacCallum Cancer Institute - East Melbourne
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Recruitment hospital [2]
1987
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Concord Repatriation Hospital - Concord
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Recruitment hospital [3]
1988
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [4]
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The Chris O’Brien Lifehouse - Camperdown
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Recruitment postcode(s) [1]
7711
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3002 - East Melbourne
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Recruitment postcode(s) [2]
7712
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2138 - Concord West
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Recruitment postcode(s) [3]
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3050 - Royal Melbourne Hospital
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Recruitment postcode(s) [4]
7714
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2050 - Missenden Road
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Cancer Council Australia
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Address [1]
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Level 14, 477 Pitt Street,
Sydney NSW 2000
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Country [1]
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Australia
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Funding source category [2]
288591
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Other Collaborative groups
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Name [2]
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Sydney Catalyst
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Address [2]
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Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country [2]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Psychooncology Cooperative Research Group
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Address
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
287298
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Other Collaborative groups
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Name [1]
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Australia and New Zealand Urogenital and Prostate Cancer Trials Group
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Address [1]
287298
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Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country [1]
287298
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
290453
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SLHD Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
290453
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Research Development Office RPAH Medical Centre Suite 210A, 100 Carillon Avenue NEWTOWN NSW 2042
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Ethics committee country [1]
290453
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Australia
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Date submitted for ethics approval [1]
290453
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25/11/2013
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Approval date [1]
290453
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Ethics approval number [1]
290453
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Ethics committee name [2]
290454
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Peter MacCallum Cancer Centre Ethics Committee
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Ethics committee address [2]
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Ethics Committee Secretariat
Peter MacCallum Cancer Centre
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
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Ethics committee country [2]
290454
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Australia
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Date submitted for ethics approval [2]
290454
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25/11/2013
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Approval date [2]
290454
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Ethics approval number [2]
290454
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Summary
Brief summary
This research project is aimed at developing and assessing the feasibility and acceptability of an online program for men who have undergone treatment for testicular cancer. The program has been designed to reduce distress and address the needs of these men. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more who has completed treatment for testicular cancer between 6 months to 5 years ago, and have no evidence of disease recurrence. You will need to have access to computer at least weekly for up to 10 weeks. Study details All participants in this study will receive an online intervention to address the specific unmet needs of testicular cancer survivors (such as for help with fear of cancer recurrence, body image and sexual issues, financial issues and re-establishing a sense of normal), as well as general anxiety and depression.The intervention involves completion of 6 online modules in 10 weeks. On completion of the intervention at 10 weeks, participants will be asked to complete a number of questionnaires about the feasibility, acceptability, utility, comprehensiveness, relevance, helpfulness, and simplicity of the intervention.
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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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Prof Phyllis Butow
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Address
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The University of Sydney
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country
45778
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Australia
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Phone
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+61 2 9351 2859
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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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Dr Louise Heiniger
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Address
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The University of Sydney
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country
45779
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Australia
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Phone
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+61 2 9036 5291
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Fax
45779
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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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Prof Phyllis Butow
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Address
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The University of Sydney
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 9351 2859
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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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