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Trial registered on ANZCTR


Registration number
ACTRN12624001331527p
Ethics application status
Submitted, not yet approved
Date submitted
30/09/2024
Date registered
1/11/2024
Date last updated
1/11/2024
Date data sharing statement initially provided
1/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrition impact symptoms experienced during cancer treatment: A cross-sectional survey
Scientific title
Nutrition impact symptom experienced during cancer treatment: A cross-sectional survey exploring symptom incidence, frequency, severity, interference with eating and drinking, met and unmet needs, and perceived importance.
Secondary ID [1] 313077 0
Nil
Universal Trial Number (UTN)
Trial acronym
NIS Survey
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 335316 0
nutrition impact symptoms 335317 0
cancer-related effects 335318 0
Condition category
Condition code
Cancer 331892 331892 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
Nutrition impact symptoms (NIS) are defined as symptoms that affect food intake or choice and increase the risk of undernutrition. NIS are often induced by cancer treatment.

In a once-off survey, a total of 27 NIS experienced since starting any cancer treatment will be assessed:
1. Nausea
2. Vomiting
3. Diarrhoea
4. Constipation
5. Reflux, indigestion, or heartburn
6. Hiccups
7. Dry mouth or thick saliva
8. Difficulty chewing
9. Difficulty swallowing
10. Mouth pain or sores
11. Skin cracking in the corners of the mouth
12. Throat pain or sores
13. Pain (not including mouth or throat pain)
14. Stomach bloating or abdominal discomfort
15. Feeling full quickly after eating or drinking
16. Poor appetite
17. Altered smell of foods or drinks
18. Altered taste of foods or drinks
19. Difficulty breathing
20. Feeling drowsy
21. Fatigue
22. Feeling sad
23. Feeling anxious or worried
24. Feeling stressed
25. Worrying about finances
26. Feeling lonely or unsupported by family and friends
27. Lack of confidence or ability to prepare foods

The survey will be completed online (powered by REDCap) with the link made available after signing the eConsent form. Alternatively the survey can be completed via a mailed paper-based form, if one is requested. The survey will take approximately 15-20 minutes to complete.
Intervention code [1] 329635 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339507 0
Total nutrition impact symptom score
Timepoint [1] 339507 0
One timepoint only; at any stage in a persons cancer journey
Secondary outcome [1] 440229 0
Nutrition impact symptom incidence
Timepoint [1] 440229 0
One timepoint only; at any stage in a persons cancer journey.
Secondary outcome [2] 440230 0
Nutrition impact symptom frequency
Timepoint [2] 440230 0
One timepoint only; at any stage in a persons cancer journey.
Secondary outcome [3] 440231 0
Nutrition impact symptom severity
Timepoint [3] 440231 0
One timepoint only; at any stage in a persons cancer journey.
Secondary outcome [4] 440232 0
Frequency of nutrition impact symptom interference with food and drink intake
Timepoint [4] 440232 0
One timepoint only; at any stage in a persons cancer journey.
Secondary outcome [5] 440233 0
Incidence of nutrition impact symptom unmet needs
Timepoint [5] 440233 0
One timepoint only; at any stage in a persons cancer journey
Secondary outcome [6] 440234 0
Perceived importance of nutrition impact symptom monitoring
Timepoint [6] 440234 0
One timepoint only; at any stage in a persons cancer journey
Secondary outcome [7] 440237 0
Nutrition impact symptom survey comprehensiveness
Timepoint [7] 440237 0
One timepoint only; at any stage in a persons cancer journey
Secondary outcome [8] 440238 0
Nutrition impact symptom survey relevance
Timepoint [8] 440238 0
One timepoint only; at any stage in a persons cancer journey
Secondary outcome [9] 440239 0
Nutrition impact symptom survey comprehensibility
Timepoint [9] 440239 0
One timepoint only; at any stage in a persons cancer journey

Eligibility
Key inclusion criteria
• Any cancer type.
• Have undergone at least one cancer treatment session within the past month.
• Any cancer treatment type.
Minimum age
No limit
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe cognitive impairment preventing ability to fully understand the purpose of the study and complete the survey.
• Unable to understand English language and translator unavailable.
• Parenteral or enteral nutrition.
• Participants with other factors deemed by the Investigators as not suitable for the trial.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26581 0
Netherlands
State/province [1] 26581 0
Country [2] 26582 0
Japan
State/province [2] 26582 0
Country [3] 26583 0
United States of America
State/province [3] 26583 0
Country [4] 26584 0
Indonesia
State/province [4] 26584 0
Country [5] 26585 0
Philippines
State/province [5] 26585 0
Country [6] 26586 0
United Kingdom
State/province [6] 26586 0
Country [7] 26587 0
France
State/province [7] 26587 0
Country [8] 26588 0
New Zealand
State/province [8] 26588 0
Country [9] 26589 0
Ireland
State/province [9] 26589 0
Country [10] 26590 0
India
State/province [10] 26590 0
Country [11] 26591 0
Hong Kong
State/province [11] 26591 0

Funding & Sponsors
Funding source category [1] 317521 0
University
Name [1] 317521 0
Queensland University of Technology
Country [1] 317521 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319823 0
None
Name [1] 319823 0
Address [1] 319823 0
Country [1] 319823 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316233 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316233 0
https://metrosouth.health.qld.gov.au/research/about-us/hrec
Ethics committee country [1] 316233 0
Australia
Date submitted for ethics approval [1] 316233 0
30/09/2024
Approval date [1] 316233 0
Ethics approval number [1] 316233 0

Summary
Brief summary
Nutrition impact symptoms (NIS) are symptoms that affect food intake or choice and increase the risk of undernutrition. Contributing to the high prevalence, burden, and suboptimal management of NIS is the lack of a patient-reported tool that comprehensively assesses NIS.

Therefore, in people undergoing cancer treatment, a cross-sectional survey will aim to assess nutrition impact symptom (NIS) incidence, frequency, and severity; frequency of NIS interference with eating and drinking; met and unmet NIS needs; and perceived importance of NIS.

In a minimum of 100 participants, 27 patient-reported NIS will be assessed using a researcher-developed survey due to the lack of a comprehensive NIS tool existing. The comprehensiveness, relevance, and comprehensibility of the NIS survey will be assessed to aid in the further development and validation of the NIS tool.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137230 0
Dr Megan Crichton
Address 137230 0
Queensland University of Technology, Cancer and Palliative Care Outcomes Centre, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 137230 0
Australia
Phone 137230 0
+61 7 3138 6322
Fax 137230 0
Email 137230 0
[email protected]
Contact person for public queries
Name 137231 0
Megan Crichton
Address 137231 0
Queensland University of Technology, Cancer and Palliative Care Outcomes Centre, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 137231 0
Australia
Phone 137231 0
+61 7 3138 6322
Fax 137231 0
Email 137231 0
[email protected]
Contact person for scientific queries
Name 137232 0
Megan Crichton
Address 137232 0
Queensland University of Technology, Cancer and Palliative Care Outcomes Centre, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 137232 0
Australia
Phone 137232 0
+61 7 3138 6322
Fax 137232 0
Email 137232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Megan Crichton, Queensland University of Technology, [email protected]).


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.