Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000246482
Ethics application status
Approved
Date submitted
24/11/2014
Date registered
22/02/2016
Date last updated
7/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Delivering a very early nutrition intervention for patients with upper gastrointestinal and lung cancers at home using technology: a pilot randomised trial.
Scientific title
For patients newly diagnosed with upper gastrointestinal or lung cancer, will an early intensive nutrition intervention delivered via an e-platform, as compared to early intensive nutrition intervention delivered via the telephone versus standard nutrition treatment, improve health-related quality of life and nutritional status.
Secondary ID [1] 285718 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper gastrointestinal cancer 293597 0
Lung cancer 293598 0
Condition category
Condition code
Cancer 293883 293883 0 0
Stomach
Cancer 293884 293884 0 0
Oesophageal (gullet)
Cancer 293885 293885 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an early and intensive nutrition counselling delivered via an e-platform on an iPad using an app called myPace. This App is installed on the iPad and provides a medium for nutrition information materials, nutritional advice via email and text reminders to be accessible by participants at home via text messages. The iPad also contains a repository of resources such as diet tips and how to manage symptoms such as nausea via dietary changes. Relevant resources can be emailed to the patient by the dieititian. who tailors advice to each participant with an emphasis on addressing current and anticipated nutrition-related symptoms. Participants will also be able to ask questions to the dietitian via this medium. The patient self monitor their weight and symptoms and send then via the App directly to their dietitian. The dietititan can respond each week via email or text and each counselling session takes 15-30 minutes depending on the complexity of the advice provided.
The telephone intervention is similar in content to the e-intervention but delivered by regular weekly phone calls and written resources posted via the mail to the patient.

The duration of these interventions are approximately 18 weeks from shortly after diagnosis and throughout the cancer treatment journey which is individualised. The participants will be able to access the mobile device for 26 weeks although dietetic contact via the e-platform will cease at about 18 weeks.
Intervention code [1] 290675 0
Behaviour
Intervention code [2] 293717 0
Lifestyle
Comparator / control treatment
There will be a comparator treatment and also a control group assigned for this study.

The comparator treatment is early and intensive nutrition counselling delivered via the telephone. Participants assigned to this group will receive nutrition assessment and advice from the dietitian via weekly telephone calls which last between 10 and 30 minutes each. Participants would also receive face-to-face contact with the dietitian when they were admitted for treatment. The nutrition approach will be tailored by the dietitian to each participant with an emphasis on addressing current and anticipated nutrition-related symptoms. Participants will receive nutrition information materials and provided forms to order supplements when deemed necessary by the dietitian.

The duration of this intervention is approximately 18 weeks from shortly after diagnosis and throughout the chemotherapy/surgery treatment trajectory with a follow up at 26 weeks.



Control group

The control group will receive standard nutrition treatment. Participants will only receive nutrition intervention from the dietitian if they are screened by a health professional and deemed to be at risk of malnutrition upon commencement of treatment. Participants will be seen by the dietitian and assessed whether they will require nutrition information materials and nutritional supplements. The duration of standard nutrition treatment will vary depending on the dietitian's assessment of the participant's progress.
Control group
Active

Outcomes
Primary outcome [1] 293666 0
Health-Related Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Global Quality of Life questionnaire C30 (EORTC QLQ C30) and EQ-5D.
Timepoint [1] 293666 0
Four timepoints for the collection of Health-Related Quality of Life. These are baseline = at time of diagnosis; early follow-up = at commencement of surgery; mid follow-up = at commencement of neoadjuvant chemotherapy and at 26 weeks = end of study.
Secondary outcome [1] 311535 0
Nutritional status as measured by the Patient-Generated Subjective Global Assessment.
Timepoint [1] 311535 0
Four timepoints for the collection of nutritional status. These are baseline = at time of diagnosis; early follow-up = at commencement of surgery; mid follow-up = at commencement of neoadjuvant chemotherapy and at 26 weeks = end of study.

Eligibility
Key inclusion criteria
1. A new histological diagnosis of cancer of the upper gastrointestinal or lung cancer and are to undergo surgery and/or chemotherapy and/or definitive chemoradiotherapy
2. 18 years or over
3. Competency to consent
4. Provision of consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative care only is being provided

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was completed with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analyses will be used for the primary and secondary outcomes over the follow-up assessment time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/12/2014
Date of last participant enrolment
Anticipated
23/12/2016
Actual
9/02/2016
Date of last data collection
Anticipated
Actual
12/08/2016
Sample size
Target
30
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3193 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 3194 0
Epworth Richmond - Richmond
Recruitment hospital [3] 3195 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 8974 0
3189 - Moorabbin
Recruitment postcode(s) [2] 8975 0
3121 - Richmond
Recruitment postcode(s) [3] 8976 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 290294 0
Charities/Societies/Foundations
Name [1] 290294 0
Nutricia Research Foundation
Country [1] 290294 0
Netherlands
Primary sponsor type
University
Name
Monash University
Address
Department of Nutrition and Dietetics
Monash University, School of Clinical Sciences
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 291637 0
None
Name [1] 291637 0
Address [1] 291637 0
Country [1] 291637 0
Other collaborator category [1] 278239 0
Individual
Name [1] 278239 0
Ms June Savva
Address [1] 278239 0
Monash Cancer Centre/Moorabbin Hospital
Level 3 Allied Health
823 Centre Road
Bentleigh East VIC 3165
Country [1] 278239 0
Australia
Other collaborator category [2] 278240 0
Individual
Name [2] 278240 0
Dr Catherine Huggins
Address [2] 278240 0
Department of Nutrition and Dietetics
Monash University, School of Clinical Sciences
Level 1, 264 Ferntree Gully Road
Notting Hll VIC 3168
Country [2] 278240 0
Australia
Other collaborator category [3] 278241 0
Individual
Name [3] 278241 0
Professor Terrance Haines
Address [3] 278241 0
Director of Allied Health, Monash Health and Department of Physiotherapy
School of Primary Health Care
Faculty of Medicine, Nursing and Health Science
Monash University
PO Box 527 Frankston Vic 3199
Country [3] 278241 0
Australia
Other collaborator category [4] 278242 0
Individual
Name [4] 278242 0
Alastair Kwok
Address [4] 278242 0
Department of Nutrition and Dietetics
Monash University
1/264 Ferntree Gully Road
Notting Hill VIC 3168
Country [4] 278242 0
Australia
Other collaborator category [5] 278243 0
Hospital
Name [5] 278243 0
Monash Health
Address [5] 278243 0
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country [5] 278243 0
Australia
Other collaborator category [6] 278787 0
Individual
Name [6] 278787 0
Ms Maryanne Silvers
Address [6] 278787 0
Department of Nutrition and Dietetics
Monash Health
Monash Medical Centre
Clayton Road
Clayton 3168
Victoria
Country [6] 278787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292002 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 292002 0
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 292002 0
Australia
Date submitted for ethics approval [1] 292002 0
Approval date [1] 292002 0
20/03/2014
Ethics approval number [1] 292002 0
10267B

Summary
Brief summary
This study will investigate the impact of early nutrition counselling delivered electronically on health-related quality of life and nutritional status in patients diagnosed with stomach or oesophageal or lung cancer compared with both early nutrition counselling delivered via the telephone and standard nutrition care.

You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with upper gastrointestinal (GI) cancer or lung cancer and are being treated at Monash Health and your consultant is agreeable.

Participants in this study are randomly allocated (by chance) to one of three groups. Participants in one group will receive early nutrition counselling delivered electronically via a mobile device (ipad). Participants in another group will receive early nutrition counselling delivered via telephone. Participants in the third group will receive standard nutrition care as deemed necessary by their health professional. Participants with early nutrition intervention will receive contact from the dietitian for the first 18 weeks of the study. Health-related quality of life and nutritional status will be assessed by questionnaires throughout the study up to 26 weeks.
Trial website
Trial related presentations / publications
Public notes
Study was submitted for registration in November 2014, prior to recruitment commencing in December 2014.
The study was amended to include patients with cancer of the lung in February 2016.

Contacts
Principal investigator
Name 52998 0
Prof Helen Truby
Address 52998 0
Monash University Nutrition and Dietetics Department
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 52998 0
Australia
Phone 52998 0
(+613) 9902 4261
Fax 52998 0
Email 52998 0
[email protected]
Contact person for public queries
Name 52999 0
Prof Helen Truby
Address 52999 0
Monash University Nutrition and Dietetics Department
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 52999 0
Australia
Phone 52999 0
(+613) 9902 4261
Fax 52999 0
Email 52999 0
[email protected]
Contact person for scientific queries
Name 53000 0
Prof Helen Truby
Address 53000 0
Monash University Nutrition and Dietetics Department
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 53000 0
Australia
Phone 53000 0
(+613) 9902 4261
Fax 53000 0
Email 53000 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.