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Trial registered on ANZCTR


Registration number
ACTRN12613001026718
Ethics application status
Approved
Date submitted
29/08/2013
Date registered
13/09/2013
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving access to psychological services for people with cancer: A randomised controlled trial of an interactive web-based intervention (CancerCope)
Scientific title
A randomised controlled trial in cancer patients with elevated psychological distress to assess the efficacy and cost-effectiveness of an interactive web-based cognitive behavioural intervention in comparison to standard patient education materials
Secondary ID [1] 283013 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 289969 0
Cancer 297905 0
Condition category
Condition code
Cancer 290196 290196 0 0
Any cancer
Public Health 290341 290341 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interactive, individualised, internet based cognitive behavioural intervention.

The intervention aims to provide information and support to patients, to help them adjust to a diagnosis of cancer and reduce their cancer-related distress. Topics will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support.
To deliver the psychological intervention, the application will include educational information and videos with self-management tools and interactive tasks tailored in response to users' needs as determined by their input. The program has high levels of interactivity - self-assessment and monitoring tools such as quizzes and online diaries - to increase user engagement and systems to encourage use and self-management including personalised email reminders, follow up and feedback.

The intervention will consist of six cores and will be metered (distributed), rather than provided all at once (like a static health information website). Cores one and two will be available immediately after completion of baseline assessment. Subsequent cores (three through to six) will be released at seven day intervals. Participants will be encouraged to complete the core within seven days of its release. It is anticipated that each core will take approximately one hour to complete. In addition to the six cores, the participant will have access to a “library” of information relevant to various challenges associated with cancer (e.g., managing fatigue, coping with treatment, managing conflict with a loved one). Following completion of all six cores, participants will be encouraged to review the core information and utilise the “library”. Participants will receive continued access to the intervention for the duration of the twelve month intervention period, to be accessed at their discretion.
Intervention code [1] 287728 0
Behaviour
Intervention code [2] 287868 0
Treatment: Other
Comparator / control treatment
Patient education.

The control arm will receive access to a static website for the duration of the 12 month intervention period, to be accessed at their discretion. The static website will contain currently available best practise and evidence-based resources. Topics will include stress management skills; problem solving approaches to cancer-related concerns; and patient education about a healthy lifestyle to promote wellness and optimise quality of life.
Control group
Active

Outcomes
Primary outcome [1] 290224 0
Psychological distress as assessed by the Brief Symptom Inventory (BSI-18) through three subscales of depression, anxiety and somatisation.
Timepoint [1] 290224 0
Baseline and at 2, 6 and 12 months after recruitment
Primary outcome [2] 290225 0
Cancer specific distress as assessed by the Impact of Event Scale (IES).
Timepoint [2] 290225 0
Baseline and at 2, 6 and 12 months after recruitment
Primary outcome [3] 290226 0
Unmet psychological supportive care needs as asessed by the Supportive Care Needs Survey Short Form 34 (SCNS-SF34).
Timepoint [3] 290226 0
Baseline and at 2, 6 and 12 months after recruitment
Secondary outcome [1] 304151 0
Positive Adjustment as measured with a 21-item Posttraumatic Growth Inventory (PTGI)
Timepoint [1] 304151 0
Baseline and at 2, 6 and 12 months after recruitment
Secondary outcome [2] 304152 0
Quality of Life and Health Economics as measured by,

a) The Assessment of Quality of Life - 8D (AQoL-8D)
b) Self report data about visits to primary healthcare providers (GPs, psychologists) and use of prescription medication on the PBS

Timepoint [2] 304152 0
Baseline and at 2, 6 and 12 months after recruitment

Eligibility
Key inclusion criteria
1) have been recently diagnosed with invasive melanoma or invasive colorectal cancer (patients will be within six months of diagnosis at recruitment)(QCR recruitment) OR be diagnosed with cancer (131120 recruitment);
2) be able to read and speak English;
3) have no previous history of head injury, dementia or psychiatric illness;
4) have no other concurrent cancer;
5) have phone and internet access;
6) have physician clearance to participate in the study (QCR recruitment only);
7) score 4 or higher on the Distress Thermometer (indicating high distress, or at risk of high distress)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Children and/or young people (ie. <18 years)
2) People with an intellectual or mental impairment

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)
Potential participants will be identified through the (1) the Queensland Cancer Registry (QCR); and (2) Cancer Council 131120. For QCR recruitment, patients who have been diagnosed with melanoma or colorectal cancer in the last 6 months will be identified through pathology records held by the QCR. The diagnosing clinician on the patient's pathology record will be contacted, seeking their consent to contact the patient. Where the doctor has given permission to contact, research staff will then send a letter to the patient (signed by the patient's doctor) inviting them to participate in the study. Informed written consent will be obtained before completing the baseline assessment.

For recruitment through Cancer Council 131120, callers who meet selection criteria will be offered entry into the study by the 131120 operator at the time of the call, and will be contacted by project staff for consent to be in the study, and to complete baseline assessment.

Randomisation to study condition will occur following the completion of baseline assessment. Allocation concealment will occur with randomisation being undertaken by computer at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in blocks of 10, with each condition randomly generated 5 times within each block to ensure an unpredictable allocation sequence with equal numbers of participants in each group at the completion of each block.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on the number of incident cancers in 2009, and projections using population growth and aging, it is estimated that approximately 6,500 Queenslanders will be diagnosed with either invasive colorectal cancer or invasive melanoma in 2013. Of these, about 5,450 will be aged 18-79 years at diagnosis (2,940 melanomas, 2,510 colorectal cancers) of which approximately 2,999 (55%) will be connected to the internet, and, of these about 50% (colorectal) and 30% (melanoma) will be defined as being distressed. This leaves about 485 eligible melanoma patients and 690 eligible colorectal cancer patients. Based on our previous studies, we anticipate that approximately 70% of doctors contacted will consent to their patient being approached. Then approximately 60% of patients approached will consent to participate.

Taking these response rates into account, the final sample of people diagnosed with invasive colorectal cancer will be 290 and for invasive melanoma will be 200, of which 245 (145 colorectal and 100 melanoma) will be randomised to the intervention and control groups. This combined sample (245 per group) will provide 91% power to detect a small effect size (0.3) with a significance level (alpha) of 0.05 using a two-sided two-sample t-test.

All analyses will be conducted on the basis of intention to treat. The study is a multivariate, two condition randomised controlled trial with repeated measures across time. We will use a multilevel model (MLM) to examine this design in which measurement occasions (level 1) are nested within persons (level 2) and in which program differences are represented as a fixed effect at level 2 whose interaction with time represents differential adjustment and distress trajectories for the two groups.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
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)
QLD

Funding & Sponsors
Funding source category [1] 287779 0
Government body
Name [1] 287779 0
National Health and Medical Research Council
Address [1] 287779 0
GPO Box 1421
CANBERRA ACT 2601
Country [1] 287779 0
Australia
Funding source category [2] 287780 0
Charities/Societies/Foundations
Name [2] 287780 0
Cancer Council Queensland
Address [2] 287780 0
PO Box 201
SPRING HILL QLD 4004
Country [2] 287780 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith Health Institute
Gold Coast Campus
Griffith University QLD 4222
Country
Australia
Secondary sponsor category [1] 286514 0
Charities/Societies/Foundations
Name [1] 286514 0
Cancer Council Queensland
Address [1] 286514 0
PO Box 201
Spring Hill QLD 4004
Country [1] 286514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289729 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 289729 0
Office for Research
Bray Centre, Nathan Campus
170 Kessels Rd
NATHAN QLD 4011
Ethics committee country [1] 289729 0
Australia
Date submitted for ethics approval [1] 289729 0
01/05/2013
Approval date [1] 289729 0
03/06/2013
Ethics approval number [1] 289729 0
PSY/70/13/HREC
Ethics committee name [2] 294560 0
Metro South Human Research Ethics Committee - Princess Alexandra Hospital
Ethics committee address [2] 294560 0
Centres for Health Research
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [2] 294560 0
Australia
Date submitted for ethics approval [2] 294560 0
16/10/2013
Approval date [2] 294560 0
03/12/2013
Ethics approval number [2] 294560 0
HREC/13/QPAH/601

Summary
Brief summary
The aim of this study is to assess the efficacy and cost-effectiveness of an interactive web-based psychological intervention for people with cancer and elevated psychological distress.

Who is it for?
Participants will be identified through notifications received by the Queensland Cancer Registry (QCR), or be referred through Cancer Council's Information and Support service 131120. Participants will be aged 18 years or above, live in Queensland, have been diagnosed with malignant melanoma or colorectal cancer within the past 6 months (QCR) OR have been diagnosed with cancer (131120), are experiencing elevated psychological distress and have phone and internet access.

Study details
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will have access to an interactive, individualised, internet based cognitive behavioural intervention. The intervention aims to provide information and support to patients, to help them adjust to a diagnosis of cancer and reduce their cancer-related distress. The intervention will include educational information and videos with self-management tools and interactive tasks tailored in response to users' needs as determined by their input. Participants in the other group will receive access to a static education website, containing information on stress management skills, problem solving approaches to cancer-related concerns, and patient education about a healthy lifestyle to promote wellness and optimise quality of life. All participants will be asked to complete a number of questionnaires at baseline, 2, 6, and 12 months, in order to assess their psychological distress and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42130 0
Prof Suzanne Chambers
Address 42130 0
Menzies Health Institute Queensland
Griffith Health Centre (G40) 8.83
Griffith University, Gold Coast Campus, QLD 4222
Country 42130 0
Australia
Phone 42130 0
+61 7 56788664
Fax 42130 0
Email 42130 0
suzanne.chambers@griffith.edu.au
Contact person for public queries
Name 42131 0
Ms Lisa Nielsen
Address 42131 0
Cancer Council Queensland
PO Box 201
Spring Hill QLD 4004
Country 42131 0
Australia
Phone 42131 0
+61 7 36345393
Fax 42131 0
Email 42131 0
lisanielsen@cancerqld.org.au
Contact person for scientific queries
Name 42132 0
Prof Suzanne Chambers
Address 42132 0
Menzies Health Institute Queensland
Griffith Health Centre (G40) 8.83
Griffith University, Gold Coast Campus, QLD 4222
Country 42132 0
Australia
Phone 42132 0
+61 7 56788664
Fax 42132 0
Email 42132 0
suzanne.chambers@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary