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Trial registered on ANZCTR


Registration number
ACTRN12616000412437
Ethics application status
Approved
Date submitted
22/03/2016
Date registered
31/03/2016
Date last updated
6/02/2019
Date data sharing statement initially provided
6/02/2019
Date results information initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and evaluation of Delta, a decision aid for parents and young people deciding whether or not to enrol in a paediatric oncology clinical trial
Scientific title
Development and pilot evaluation of a decision aid for parents and adolescents considering enrolling their child in a paediatric oncology clinical trial
Secondary ID [1] 288624 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 297780 0
Condition category
Condition code
Cancer 297963 297963 0 0
Children's - Other
Public Health 297964 297964 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A hard-copy and online decision aid about enrollment in paediatric oncology clinicial trials for parents and young patients. A decision aid is a patient information tool with an emphasis on guidance about making a decision, including value-clarification exercises.

The decision aid (DA) will be provided to parents and adolescents who have already made the decision to enrol in a clinical trial. Participants will have the option to evaluate either the hard-copy DA or the online website. The DA will be assessed for acceptability and feasibility, with time spent reviewing the DA content up to individual participants. Questionnaires will be completed prior to reviewing the DA, and immediately after reviewing the DA. The questionnaires are estimated to take approximately 10 minutes each. There is no further follow-up once completing the second questionnaire
Intervention code [1] 294027 0
Not applicable
Comparator / control treatment
There will be no comparator for this trial as it is a pilot study.. The DA will be assessed sequentially, with the hard-copy assessed firstly to confirm content is acceptable, followed by assessment of the online DA. The print DA will not be compared to the online DA.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297485 0
Acceptability of the decision aid to parents, and adolescents and young adults who have had to make a decision of whether to enrol in a paediatric oncology clinical trial in the past. This will be assessed with an online/hard-copy questionnaire designed specifically for this study, utilising validated measures where possible. We will assess overall satisfaction and acceptability of content, length and amount of information, balance in how the options were presented and emotional impact. Modality preferences of the decision aid will also be assessed.
Timepoint [1] 297485 0
Immediately after reading decision aid
Secondary outcome [1] 321173 0
Preparation for decision making (a 10-item Patient Decision Aids Research Group, Ottawa Hospital Research Institute measure)
Timepoint [1] 321173 0
Immediately before reading the decision aid.
Secondary outcome [2] 321174 0
Knowledge about clinical trials (Joffe et al. measure),
Timepoint [2] 321174 0
Immediately before and immediately after reading the decision aid
Secondary outcome [3] 321176 0
Decision Satisfaction (a 6-item scale from Holmes-Rovner et al. 1996)
Timepoint [3] 321176 0
Immediately before reading the decision aid
Secondary outcome [4] 321177 0
Decision regret (a 5-item scale from Brehaut 2003)
Timepoint [4] 321177 0
Immediately before reading the decision aid
Secondary outcome [5] 321178 0
Health literacy (a 4-item BRIEF scale from Haun et al., 2003)
Timepoint [5] 321178 0
Immediately after reading decision aid
Secondary outcome [6] 321179 0
Quality of life (EQ-5D-5L)
Timepoint [6] 321179 0
Immediately after reading decision aid
Secondary outcome [7] 343432 0
SDM-Q-9 (measuring shared decision-making)
Timepoint [7] 343432 0
Immediately prior to reading the decision aid
Secondary outcome [8] 343433 0
Shared decision-making preferences scale (purpose designed)
Timepoint [8] 343433 0
Immediately prior to reivewing the decision aid
Secondary outcome [9] 343434 0
Health literacy will be measured by the FCC-HL FCC-HL (Functional, communicative and critical - health literacy)
Timepoint [9] 343434 0
Immediately before reading the decision aid
Secondary outcome [10] 343435 0
Percieved and actual clinical trial knowledge will be measured in an adapted version of the QuIC. This measure has 2 subscales - perceived knowledge measures the participants perception of their level of clinical trial knowledge in a 12 item scale. Actual clinical trial knowledge is assessed in a 17 item.
Timepoint [10] 343435 0
Immediately before and after reading the decision aid

Eligibility
Key inclusion criteria
Parent/carers of children with cancer whose child:
a) is under 18 years of age
b) has been invited to participate in the Study 9 Phase III clinical trial.

Adolescents and young adults who have been diagnosed with cancer
a) is between 12 - 18 years of age
b) has been invited to participate in the Study 9 Phase III clinical trial.

All participants will be able to (i) give informed consent/assent; and (ii) read English.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) AYAs and parents/carers who were not offered participation in a clinical trial by their treating team
b) Parents/carers with insufficient English to read the decision aid and complete questionnaires
c) Parents/carers of children who are deemed inappropriate to participate in the study by their treating oncologist due to poor psychological well-being or other psychiatric condition
d) Individuals not capable of providing fully informed consent due to any psychiatric or cognitive difficulties.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis

Recruitment
Recruitment status
Completed
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)
NSW
Recruitment hospital [1] 5346 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 10077 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 12804 0
2031 - Randwick
Recruitment postcode(s) [2] 21603 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 292983 0
Government body
Name [1] 292983 0
Cancer Institute NSW
Address [1] 292983 0
Cancer Institute NSW
Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
AUSTRALIA

Country [1] 292983 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Behavioural Sciences Unit
Address
Behavioural Sciences Unit
Kids Cancer Centre, Sydney Children's Hospital
High St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 291754 0
None
Name [1] 291754 0
Address [1] 291754 0
Country [1] 291754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294492 0
Sydney Children's Hospital Network
Ethics committee address [1] 294492 0
Kids Research Institute
Children's Hospital at Westmead
Locked Bag 4001
WESTMEAD NSW 2145
Ethics committee country [1] 294492 0
Australia
Date submitted for ethics approval [1] 294492 0
31/03/2016
Approval date [1] 294492 0
31/05/2016
Ethics approval number [1] 294492 0
LNR/16/SCHN/182

Summary
Brief summary
The primary purpose of this study is to develop and evaluate a decision aid tool for parents/carers of children with cancer, and adolescents with cancer to assist in the decision making process of clinical trial enrolment.

Who is it for?
You may be eligible to participate in this study if you are either a parent/carer of a child with cancer who has been invited to participate in the Study 9 clinical trial; or if you are aged 12-18 years of age, having had a cancer diagnosis and been invited to participate in the Study 9 clinical trial.

Study details
Parents/carers and adolescents enrolled with either receive the decision aid as a hard copy or as an online tool. They will then be asked to complete two short questionnaires (one before looking at the decision aid, and one after), including several open ended items, asking for their feedback regarding the decision aid, either by hard copy or online as chosen by each participant.

It is hoped that this study will result in an acceptable and feasible online decision aid tool, which will assist parents/carers of children with cancer, and young people with cancer with the decision of whether or not to participate in a clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63898 0
Ms Eden Robertson
Address 63898 0
Behavioural Sciences Unit
Kids Cancer Centre, Sydney Children’s Hospital

Level 1 South
High St
Randwick NSW
Australia 2031
Country 63898 0
Australia
Phone 63898 0
+612 9385 9868
Fax 63898 0
Email 63898 0
DeltaStudy@unsw.edu.au
Contact person for public queries
Name 63899 0
Ms Eden Robertson
Address 63899 0
Behavioural Sciences Unit
Kids Cancer Centre, Sydney Children’s Hospital

Level 1 South
High St
Randwick NSW
Australia 2031
Country 63899 0
Australia
Phone 63899 0
+612 9385 9868
Fax 63899 0
Email 63899 0
DeltaStudy@unsw.edu
Contact person for scientific queries
Name 63900 0
Ms Eden Robertson
Address 63900 0
Behavioural Sciences Unit
Kids Cancer Centre, Sydney Children’s Hospital

Level 1 South
High St
Randwick NSW
Australia 2031
Country 63900 0
Australia
Phone 63900 0
+612 9385 9868
Fax 63900 0
Email 63900 0
DeltaStudy@unsw.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not obtained from participants for this.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary