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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001082594
Ethics application status
Approved
Date submitted
30/09/2015
Date registered
14/10/2015
Date last updated
16/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot testing of a decision aid for nutrition support in paediatric oncology.
Scientific title
For parents and clinicians of paediatric oncology patients with malnutrition, is the decision aid about nutrition support acceptable, usable and comprehensible? (No control group)
Secondary ID [1] 287551 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition in paediatric oncology 296328 0
Condition category
Condition code
Diet and Nutrition 296604 296604 0 0
Other diet and nutrition disorders
Cancer 296713 296713 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
A print booklet decision aid about nutrition support options for treating malnutrition in paediatric oncology patients. A decision aid is a patient information booklet with an emphasis on guidance about making a decision. The options described are oral nutrition support, nasogastric tube feeding, gastrostomy tube feeding and total parenteral nutrition.
Intervention code [1] 292953 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296222 0
Acceptability of the booklet to parents. This was assessed with a seven-item questionnaire designed specifically for this study, based on previous decision aid pilot studies conducted by our team. We assessed overall satisfaction with the booklet, acceptability of length, acceptability of amount of information, balance in how the options were presented and emotional impact.
Timepoint [1] 296222 0
Immediately after reading decision aid
Primary outcome [2] 296325 0
Acceptability of the development, content and format of the booklet to clinicians. This was assessed with the questionnaire used in 'Graham, I. D., Logan, J., Bennett, C. L., Presseau, J., O'Connor, A. M., Mitchell, S. L., . . . Aaron, S. D. (2007). Physicians' intentions and use of three patient decision aids. BMC Med Inform Decis Mak, 7, 20. doi: 10.1186/1472-6947-7-2'
Timepoint [2] 296325 0
Immediately after reading decision aid
Secondary outcome [1] 317865 0
Usability of the booklet to parents. This was assessed by a two-item questionnaire used in previous decision aid pilot studies by our team, asking 'How relevant do you think the information in the booklet would be to parents/carers of children undergoing cancer treatment?' and 'Would you recommend the decision aid to others in the same situation?'.
Timepoint [1] 317865 0
Immediately after reading decision aid
Secondary outcome [2] 317866 0
Perceived improvement in understanding in parents. This was assessed using a four item questionnaire designed specifically for this study, based on previous decision aid pilot studies conducted by our team.
Timepoint [2] 317866 0
Immediately after reading decision aid
Secondary outcome [3] 318175 0
Usability of the booklet to parents/carers and clinicians, as perceived by clinicians. This was assessed with the questionnaire used in 'Graham, I. D., Logan, J., Bennett, C. L., Presseau, J., O'Connor, A. M., Mitchell, S. L., . . . Aaron, S. D. (2007). Physicians' intentions and use of three patient decision aids. BMC Med Inform Decis Mak, 7, 20. doi: 10.1186/1472-6947-7-2'
Timepoint [3] 318175 0
Immediately after reading decision aid

Eligibility
Key inclusion criteria
Parent/carers and clinicians of children who
a) have been diagnosed with cancer or a haematological condition at the Kids Cancer Centre at Sydney Children's Hospital; and
b) have had to consider nutrition support in the past five years.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inadequate English language skills

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] 4390 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 10610 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 292120 0
Other Collaborative groups
Name [1] 292120 0
Behavioural Sciences Unit, Sydney Children's Hospital
Address [1] 292120 0
Behavioural Sciences Unit
Kids Cancer Centre, Sydney Children's Hospital
High St
Randwick NSW 2031
Country [1] 292120 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Behavioural Sciences Unit, Sydney Children's Hospital
Address
Behavioural Sciences Unit
Kids Cancer Centre, Sydney Children's Hospital
High St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 290796 0
None
Name [1] 290796 0
Address [1] 290796 0
Country [1] 290796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293601 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 293601 0
Sydney Children's Hospital Network Human Research Ethics Committee
Sydney Children's Hospital
High St
Randwick NSW 2031
Ethics committee country [1] 293601 0
Australia
Date submitted for ethics approval [1] 293601 0
11/02/2015
Approval date [1] 293601 0
20/03/2015
Ethics approval number [1] 293601 0
LNR/15/SCHN/28

Summary
Brief summary
The primary purpose of this study is to investigate the acceptability, usability and comprehensibility of a decision aid which aims to help parents make a decision about nutrition support to treat malnutrition during their child's cancer treatment.
Who is it for? You may be eligible to participate in this study if you are the parent, carer or clinician of a child who has been diagnosed with cancer or a haematological condition at the Kids Cancer Centre at Sydney Children's Hospital, and have had to consider nutrition support in the past five years.
Study details: All participants recruited in this study will be asked to read the decision aid and then complete a questionnaire regarding its acceptability, usability and comprehensibility. It is hoped that the findings of this pilot study may be used to support the implementation of the decision aid to inform parents and carers facing choices regarding their children's nutrition support during cancer treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60634 0
Ms Jennifer Cohen
Address 60634 0
Kids Cancer Centre, Sydney Children’s Hospital
High St
Randwick NSW
Australia 2031
Country 60634 0
Australia
Phone 60634 0
+61 2 9382 1372
Fax 60634 0
Email 60634 0
jennifer.cohen@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 60635 0
Ms Jennifer Cohen
Address 60635 0
Kids Cancer Centre, Sydney Children’s Hospital
High St
Randwick NSW
Australia 2031
Country 60635 0
Australia
Phone 60635 0
+61 2 9382 1372
Fax 60635 0
Email 60635 0
jennifer.cohen@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 60636 0
Ms Jennifer Cohen
Address 60636 0
Kids Cancer Centre, Sydney Children’s Hospital
High St
Randwick NSW
Australia 2031
Country 60636 0
Australia
Phone 60636 0
+61 2 9382 1372
Fax 60636 0
Email 60636 0
jennifer.cohen@sesiahs.health.nsw.gov.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