Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001170718
Ethics application status
Approved
Date submitted
16/10/2013
Date registered
23/10/2013
Date last updated
23/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cancer Coping Online: evaluating the efficacy a self-guided internet intervention for reducing cancer-related distress.
Scientific title
A pilot randomised controlled trial comparing the efficacy of "Cancer Coping Online' with an information-control in reducing cancer-related distress among patients with recently diagnosed early stage cancer.
Secondary ID [1] 283406 0
Nil
Universal Trial Number (UTN)
Trial acronym
CCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 290314 0
Psychological distress 290315 0
Condition category
Condition code
Cancer 290712 290712 0 0
Any cancer
Mental Health 290713 290713 0 0
Depression
Mental Health 290714 290714 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cancer Coping Online (CCO) is a 6-week multimedia internet application, where a new module is released to participants each week, with a reminder email to use the program. The frequency in which participants will access these modules will be at the participants' discretion. Modules cover a range of commonly experienced psychosocial issues. Each module of CCO is comprised of three main components: psycho-education, cognitive-behavioural worksheets / strategies, and survivor stories and quotes. An online journal and a resource section is available throughout the duration of the program.
Website usage and adherence to the intervention is evaluated through online monitoring of the number of logins per user, the average session duration per user and the number of modules accessed and completed per user.
Intervention code [1] 288130 0
Behaviour
Intervention code [2] 288153 0
Treatment: Other
Comparator / control treatment
An online information-only version of CCO provides an appropriate attention control for the study. The control condition covers the same 6 module topics, but has no interactive features(i.e., no worksheets, activities, relaxation exercises, or journal).
Control group
Active

Outcomes
Primary outcome [1] 290715 0
General distress: the total scale score of the Depression, Anxiety, Stress Scale.
Timepoint [1] 290715 0
Pre-intervention, post-interventino, then 3 and 6 months after intervention-completion.
Primary outcome [2] 290716 0
Cancer-specific distress: the total scale score of the Post-Traumatic Stress Scale - Self Report. This is a measure of the traumatic impact of cancer diagnosis/treatment.
Timepoint [2] 290716 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion
Secondary outcome [1] 305085 0
Coping: Helplessness Hopelessness as measured by the mini-MAC
Timepoint [1] 305085 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion
Secondary outcome [2] 305086 0
Coping: Anxious Preoccupation as measured by the mini-MAC
Timepoint [2] 305086 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion
Secondary outcome [3] 305087 0
Coping: Cognitive Avoidance as measured by the mini-MAC
Timepoint [3] 305087 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion
Secondary outcome [4] 305088 0
Coping: Fatalism as measured by the mini-MAC
Timepoint [4] 305088 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion
Secondary outcome [5] 305089 0
Coping: Fighting Spirit as measured by the mini-MAC
Timepoint [5] 305089 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion
Secondary outcome [6] 305090 0
Health Related Quality of Life (QOL): Total QOL and 5 sub-domains (Role functioning, physical functioning, emotional functioning, cognitive functioning, and social functioning)

as measured by the European Organisation for Research on the Treatment of Cancer (EORTC) Quality of Life Qustionaire Cancer-30 item scale (QLQ-C30).
Timepoint [6] 305090 0
Pre-intervention, post-intervention, then 3 and 6 months after intervention-completion

Eligibility
Key inclusion criteria
1. Cancer being treated with curative intent (e.g., breast, prostate, colorectal, testicular, lymphomas, haematologic or gynaecologic malignancies)
2. Currently receiving active cancer treatment (surgery, chemotherapy, radiotherapy)
3. Age 18 years or over
4. Sufficient English language literacy
5. Access to the internet (home or work)
6. Provide an active email address and phone number
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a diagnosis of advanced cancer
(While advanced cancer patients will not be targeted for recruitment, this is a population that asks for interventions and may self-refer to the program. Therefore individuals who specifically request to participate will be enrolled, but not included in primary analyses. If a large enough sub-sample self-refers to the program, a sub-analysis will be conducted.)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation was concealed until interventions were assigned. The research assistant who contacted participants did not have access to the randomisation sequence; a separate administrator performed randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation: A computer sequence generation algorithm in blocks to either ‘intervention’ or ‘attention control’, and each condition is assigned in random order within the block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes between groups over time will be analysed using Linear Mixed Modelling, which includes all available data including from participants with missing data. Baseline differences between groups will be analysed using t-tests for continuous measures, and chi-square tests for categorical.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
1/03/2011
Date of last participant enrolment
Anticipated
1/09/2012
Actual
15/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1595 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 7472 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 288129 0
Government body
Name [1] 288129 0
Department of Health, SA

Australian Better Health Initiative Cancer Coordination Project Grant.
Country [1] 288129 0
Australia
Funding source category [2] 288130 0
University
Name [2] 288130 0
Flinders University Faculty Research Support Grant
Country [2] 288130 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology
GPO Box 2100
Adelaide
SA, 5001
Country
Australia
Secondary sponsor category [1] 286847 0
None
Name [1] 286847 0
Address [1] 286847 0
Country [1] 286847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290044 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290044 0
Ethics committee country [1] 290044 0
Australia
Date submitted for ethics approval [1] 290044 0
26/08/2010
Approval date [1] 290044 0
28/09/2010
Ethics approval number [1] 290044 0
372.10

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

Contacts
Principal investigator
Name 43682 0
Dr Lisa Beatty
Address 43682 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 43682 0
Australia
Phone 43682 0
+61 8 8201 2506
Fax 43682 0
Email 43682 0
[email protected]
Contact person for public queries
Name 43683 0
Lisa Beatty
Address 43683 0
School of Psychology, Flinders University GPO Box 2100 Adelaide, SA, 5001
Country 43683 0
Australia
Phone 43683 0
+61 8 8201 2506
Fax 43683 0
Email 43683 0
[email protected]
Contact person for scientific queries
Name 43684 0
Lisa Beatty
Address 43684 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide SA 5001
Country 43684 0
Australia
Phone 43684 0
+61 8 8201 2506
Fax 43684 0
Email 43684 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEvaluating the efficacy of a self-guided Web-based CBT intervention for reducing cancer-distress: a randomised controlled trial.2016https://dx.doi.org/10.1007/s00520-015-2867-6
N.B. These documents automatically identified may not have been verified by the study sponsor.