Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000081415
Ethics application status
Approved
Date submitted
17/01/2016
Date registered
25/01/2016
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Travel for trials: Examining cancer patients’ willingness to travel to participate in a clinical trial
Scientific title
Travel for trials: Examining cancer patients’ willingness to travel to participate in a clinical trial
Secondary ID [1] 288335 0
None
Universal Trial Number (UTN)
U1111-1178-5997
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 297310 0
Condition category
Condition code
Cancer 297510 297510 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional survey. Participants will be asked to complete a questionnaire at a single time point, with no subsequent follow-up. They will have the option of completing the questionnaire using paper and pen, or online. This can occur at either the oncology clinic, or at home at a later time. The questionnaire has been designed specifically for this survey. It will take approximately 10 minutes to complete. It asks questions about demographics, cancer diagnosis, treatment, and about preferences when considering a clinical trial. This will take the form of a discrete choice experiment, with ten scenarios per questionnaire. Participants will be asked to state whether they would join a clinical trial or continue with standard care, given the scenario presented.
Intervention code [1] 293630 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297069 0
Willingness to travel to participate in a clinical trial, assessed using a discrete choice experiment survey designed specifically for this study. Participants will be asked to state a preference, given a variety of different situations relating to clinical trial participation, of whether they would be interested in considering that clinical trial.
Timepoint [1] 297069 0
Baseline
Secondary outcome [1] 319955 0
Willingness to change healthcare provider to participate in a clinical trial, assessed using a questionnaire designed specifically for this study, as above.
Timepoint [1] 319955 0
Baseline

Eligibility
Key inclusion criteria
Diagnosis of cancer
English language sufficient for completion of questionnaire
Attending a cancer clinic for management of cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous completion of this questionnaire.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Factors in this model can be quantitatively measured against each other, for example to measure how far a patient is willing to travel to participate in a trial for a new treatment vs not participating in a trial and keeping their usual oncologist. The dependent variable will be the hypothetical choice of trial participation vs not, and explanatory variables will be the listed attributes. The results will be analysed uncorrected and corrected for demographic and disease factors in a multinomial logit model, with different regression coefficients for different demographic subgroups separately, such as rural vs urban.

The design above yields a total of 96 different trial scenarios (3x2x4x2x2). Estimating a main-effects-only cumulative link model for a design of this size requires approximately 20 observations per scenario. We anticipate collecting data from 10 scenarios per participant, which implies a target sample size of 192 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2016
Actual
1/06/2016
Date of last participant enrolment
Anticipated
3/03/2017
Actual
16/02/2017
Date of last data collection
Anticipated
Actual
16/02/2017
Sample size
Target
192
Accrual to date
Final
441
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5054 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 5055 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 5056 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [4] 5057 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [5] 5058 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 12541 0
2298 - Waratah
Recruitment postcode(s) [2] 12542 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 12543 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 12544 0
2340 - Tamworth
Recruitment postcode(s) [5] 12545 0
2430 - Taree

Funding & Sponsors
Funding source category [1] 292699 0
Other Collaborative groups
Name [1] 292699 0
Hunter Cancer Research Alliance
Country [1] 292699 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
2 Edith St
Waratah
NSW 2298
Country
Australia
Secondary sponsor category [1] 291426 0
None
Name [1] 291426 0
None
Address [1] 291426 0
None
Country [1] 291426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294182 0
Hunter New England Local Health District Human Reseach Ethics Committee
Ethics committee address [1] 294182 0
Ethics committee country [1] 294182 0
Australia
Date submitted for ethics approval [1] 294182 0
29/01/2016
Approval date [1] 294182 0
23/03/2016
Ethics approval number [1] 294182 0
LNR/16/HNE/68

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

Contacts
Principal investigator
Name 62786 0
Dr Nicholas Zdenkowski
Address 62786 0
Surgical Oncology
Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2305
Country 62786 0
Australia
Phone 62786 0
+61 2 49850134
Fax 62786 0
+61 2 49850135
Email 62786 0
[email protected]
Contact person for public queries
Name 62787 0
Nicholas Zdenkowski
Address 62787 0
Surgical Oncology
Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2305
Country 62787 0
Australia
Phone 62787 0
+61 2 49850134
Fax 62787 0
+61 2 49850135
Email 62787 0
[email protected]
Contact person for scientific queries
Name 62788 0
Nicholas Zdenkowski
Address 62788 0
Surgical Oncology
Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2305
Country 62788 0
Australia
Phone 62788 0
+61 2 49850134
Fax 62788 0
+61 2 49850135
Email 62788 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.