Trial Review

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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
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
Secondary ID [1] 283958 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
e-TC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 290984 0
testicular cancer 290985 0
Condition category
Condition code
Cancer 291329 291329 0 0
Testicular
Mental Health 291371 291371 0 0
Depression
Mental Health 291372 291372 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288645 0
Behaviour
Intervention code [2] 288666 0
Treatment: Other
Comparator / control treatment
uncontrolled intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291316 0
acceptability - measured using qualitative assessments of participant comments entered as free text on the website for each module
Timepoint [1] 291316 0
10 weeks
Primary outcome [2] 291348 0
feasibility - measured using qualitative assessments of participant comments entered as free text on the website for each module
Timepoint [2] 291348 0
10 weeks
Primary outcome [3] 291349 0
utility - measured using qualitative assessments of participant comments entered as free text on the website for each module
Timepoint [3] 291349 0
10 weeks
Secondary outcome [1] 306500 0
fear of cancer recurrence -using the the Fear of Recurrence Scale (FRS)
Timepoint [1] 306500 0
10 weeks
Secondary outcome [2] 306563 0
psychological distress - using the Hospital and Anxiety and Depression Scale (HADs)
Timepoint [2] 306563 0
10 weeks
Secondary outcome [3] 306564 0
unmet supportive care need - using the Unmet Supportive Care Needs Survey (SCNS)
Timepoint [3] 306564 0
10 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Men who completed treatment less than 6 months ago
2. Men experiencing recurrent disease

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
pre-post analysis of measures, qualitative analysis of free text items

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2014
Actual
Date of last participant enrolment
Anticipated
31/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 1986 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 1987 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 1988 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 1998 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 7714 0
2050 - Missenden Road
Recruitment postcode(s) [2] 7712 0
2138 - Concord West
Recruitment postcode(s) [3] 7711 0
3002 - East Melbourne
Recruitment postcode(s) [4] 7713 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 288590 0
Charities/Societies/Foundations
Name [1] 288590 0
Cancer Council Australia
Country [1] 288590 0
Australia
Funding source category [2] 288591 0
Other Collaborative groups
Name [2] 288591 0
Sydney Catalyst
Country [2] 288591 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Psychooncology Cooperative Research Group
Address
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 287298 0
Other Collaborative groups
Name [1] 287298 0
Australia and New Zealand Urogenital and Prostate Cancer Trials Group
Address [1] 287298 0
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country [1] 287298 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290453 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290453 0
Research Development Office RPAH Medical Centre Suite 210A, 100 Carillon Avenue NEWTOWN NSW 2042
Ethics committee country [1] 290453 0
Australia
Date submitted for ethics approval [1] 290453 0
25/11/2013
Approval date [1] 290453 0
Ethics approval number [1] 290453 0
Ethics committee name [2] 290454 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [2] 290454 0
Ethics Committee Secretariat
Peter MacCallum Cancer Centre
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [2] 290454 0
Australia
Date submitted for ethics approval [2] 290454 0
25/11/2013
Approval date [2] 290454 0
Ethics approval number [2] 290454 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45778 0
Prof Phyllis Butow
Address 45778 0
The University of Sydney
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country 45778 0
Australia
Phone 45778 0
+61 2 9351 2859
Fax 45778 0
Email 45778 0
phyllis.butow@sydney.edu.au
Contact person for public queries
Name 45779 0
Dr Louise Heiniger
Address 45779 0
The University of Sydney
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country 45779 0
Australia
Phone 45779 0
+61 2 9036 5291
Fax 45779 0
Email 45779 0
louise.heiniger@sydney.edu.au
Contact person for scientific queries
Name 45780 0
Prof Phyllis Butow
Address 45780 0
The University of Sydney
Chris O'Brien Lifehouse
University of Sydney
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country 45780 0
Australia
Phone 45780 0
+61 2 9351 2859
Fax 45780 0
Email 45780 0
phyllis.butow@sydney.edu.au

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.