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Trial registered on ANZCTR


Registration number
ACTRN12608000273381
Ethics application status
Approved
Date submitted
26/05/2008
Date registered
29/05/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Cluster randomised controlled trial of the impact of the Australian Cancer Trials online website
Scientific title
Cluster randomised controlled trial of the impact of the Australian Cancer Trials online website on the proportion of patients with whom the possibility of participation in any clinical trial is discussed with their medical oncologist.
Secondary ID [1] 253307 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACT Online
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 3207 0
Condition category
Condition code
Cancer 3371 3371 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Australian Cancer Trials Online website. This will be a website that provides up to date information about the cancer clinical trials currently recruiting patients in Australia. It will contain two decision support tools (a question prompt list and decision aid) and consumer support information which will help consumers make a decision whether to participate in a clinical trial and increase their knowledge and understanding of cancer clinical trials. Medical oncologists and patients in the intervention arm will have access to the website. The consultation between each of the participating medical oncologists and their patients will be audio-taped. Each patient will have their consultation audio-taped once. The duration of the intervention is for 6 months.
Intervention code [1] 2947 0
Other interventions
Comparator / control treatment
No access to the ACT Online website
Control group
Active

Outcomes
Primary outcome [1] 3827 0
Proportion of patients with whom the possibility of participation in any clinical trial is discussed
Timepoint [1] 3827 0
To be recorded during the audio-taped consultation
Secondary outcome [1] 6452 0
Number and complexity of issues about trials discussed in consultation
Timepoint [1] 6452 0
To be recorded during the audio-taped consultation
Secondary outcome [2] 6453 0
Consultation length
Timepoint [2] 6453 0
To be recorded during the audio-taped consultation
Secondary outcome [3] 6454 0
Proportion of patients recruited to a clinical trial using an online patient questionnaire
Timepoint [3] 6454 0
Two weeks after audio-taped consultation
Secondary outcome [4] 6455 0
Patient understanding of clinical trials and attitudes toward randomized trials will be assessed using an 8 item scale using an online questionnaire
Timepoint [4] 6455 0
Two weeks after audio-taped consultation
Secondary outcome [5] 6456 0
Quality of patients decision making will be assessed by the Decisional Conflict Scale using an online questionnaire
Timepoint [5] 6456 0
Two weeks after audio-taped consultation
Secondary outcome [6] 6457 0
Doctor attitudes to clinical trials using a modified version of the Physician Orientation Profile using an online questionnaire
Timepoint [6] 6457 0
At baseline (after randomisation) and one month after audio-taped consultation

Eligibility
Key inclusion criteria
Patients invited to participate in the study must be: 1) Patients starting treatment for the first time. For example: new patients, patients not initially suitable for chemotherapy but are currently suitable due to symptomatic disease or improved performance status. 2) Patients in whom a treatment change is anticipated. For example: in the adjuvant setting a patient with early breast cancer finishing adjuvant chemotherapy and about to start adjuvant endocrine therapy and in the metastatic setting patients with progressive disease needing to change chemotherapy or all lines of chemotherapy utilised. 3) Patients with email and internet access. 4) Patients due to see their medical oncologist in 2 weeks time over a period of 4 to 8 weeks (longer may be necessary).
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical oncologists working outside NSW and Victoria and medical oncologists who do not have email and internet access. Patients who do not have email and internet access, who are already participating in a clinical trial and do not have command of English.

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)
Concealed allocation. Medical oncology sites will be randomly assigned to intervention or control using a central computer and allocation sequence to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. A random sample of 40 sites was obtained using a stratification procedure (NSW:Vic 1:1; rural:metro 1:2 and weighting given to larger sites). From these sites 1 medical oncologist at each site was sampled (40 medical oncologists in total). 30 medical oncology sites were randomised as above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The trial is a cluster randomized trial in which doctors (medical oncologists) are the unit of randomization. 15 medical oncologists will be in the intervention (website) group and 15 medical oncologists will be in the control (no website access) group. Each of the 30 medical oncologists will invite 20 of their patients to participate in the trial ie 600 patients in total (300 in each arm of the study).
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 682 0
3084
Recruitment postcode(s) [2] 683 0
2060
Recruitment postcode(s) [3] 684 0
2135
Recruitment postcode(s) [4] 685 0
2217
Recruitment postcode(s) [5] 686 0
2139
Recruitment postcode(s) [6] 687 0
2450
Recruitment postcode(s) [7] 688 0
2010
Recruitment postcode(s) [8] 689 0
2145
Recruitment postcode(s) [9] 690 0
3084
Recruitment postcode(s) [10] 691 0
3144
Recruitment postcode(s) [11] 692 0
3002
Recruitment postcode(s) [12] 693 0
3199
Recruitment postcode(s) [13] 694 0
3165
Recruitment postcode(s) [14] 695 0
3125
Recruitment postcode(s) [15] 696 0
3058
Recruitment postcode(s) [16] 697 0
3220
Recruitment postcode(s) [17] 698 0
3181
Recruitment postcode(s) [18] 866 0
2605
Recruitment postcode(s) [19] 867 0
2148
Recruitment postcode(s) [20] 868 0
2576
Recruitment postcode(s) [21] 869 0
2795
Recruitment postcode(s) [22] 870 0
2050
Recruitment postcode(s) [23] 871 0
2350
Recruitment postcode(s) [24] 872 0
2485
Recruitment postcode(s) [25] 873 0
2444
Recruitment postcode(s) [26] 874 0
3002
Recruitment postcode(s) [27] 878 0
8006
Recruitment postcode(s) [28] 879 0
3065
Recruitment postcode(s) [29] 880 0
3844
Recruitment postcode(s) [30] 881 0
3550
Recruitment postcode(s) [31] 882 0
3350

Funding & Sponsors
Funding source category [1] 3425 0
Government body
Name [1] 3425 0
NHMRC
Country [1] 3425 0
Australia
Primary sponsor type
Individual
Name
Dr Rachel Dear
Address
Department of Cancer Medicine
Blackburn Building, D06
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 3067 0
Individual
Name [1] 3067 0
A/Prof Alex Barratt
Address [1] 3067 0
School of Public Health
Edward Ford Building, A27
The University of Sydney NSW 2006
Country [1] 3067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5020 0
Ethics committee address [1] 5020 0
Ethics committee country [1] 5020 0
Date submitted for ethics approval [1] 5020 0
Approval date [1] 5020 0
Ethics approval number [1] 5020 0
Ethics committee name [2] 5447 0
Sydney University Human Research Ethics Committee
Ethics committee address [2] 5447 0
Ethics committee country [2] 5447 0
Australia
Date submitted for ethics approval [2] 5447 0
Approval date [2] 5447 0
17/03/2008
Ethics approval number [2] 5447 0
10619
Ethics committee name [3] 6060 0
RPAH Human Research Ethics Committee
Ethics committee address [3] 6060 0
Ethics committee country [3] 6060 0
Australia
Date submitted for ethics approval [3] 6060 0
Approval date [3] 6060 0
06/08/2008
Ethics approval number [3] 6060 0
X08-0180

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

Contacts
Principal investigator
Name 28362 0
Address 28362 0
Country 28362 0
Phone 28362 0
Fax 28362 0
Email 28362 0
Contact person for public queries
Name 11519 0
Dr Rachel Dear
Address 11519 0
Department of Cancer Medicine
Blackburn Building, D06
The University of Sydney NSW 2006
Country 11519 0
Australia
Phone 11519 0
02 9351 6171
Fax 11519 0
02 9351 4317
Email 11519 0
[email protected]
Contact person for scientific queries
Name 2447 0
Dr Rachel Dear
Address 2447 0
Department of Cancer Medicine
Blackburn Building, D06
The University of Sydney NSW 2006
Country 2447 0
Australia
Phone 2447 0
02 9351 6171
Fax 2447 0
02 9351 4317
Email 2447 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
No additional documents have been identified.