Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

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
ACTRN12617000152325
Ethics application status
Approved
Date submitted
24/12/2016
Date registered
27/01/2017
Date last updated
13/08/2019
Date data sharing statement initially provided
17/05/2019
Date results information initially provided
13/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing quality of life for people with upper gastrointestinal cancer through early and intensive nutrition care delivered by telephone or mobile electronic messages.
Scientific title
Effect of early and intensive nutrition care, delivered via telephone or electronic mobile application, on quality of life in people with upper gastrointestinal cancer: a randomised controlled trial.
Secondary ID [1] 290278 0
N/A
Universal Trial Number (UTN)
Trial acronym
TEND (Telephone or electronic nutrition care delivery) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper gastrointestinal cancer 300514 0
Condition category
Condition code
Cancer 300372 300372 0 0
Oesophageal (gullet)
Cancer 300373 300373 0 0
Pancreatic
Cancer 300374 300374 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME THAT DESCRIBES THE INTERVENTION
INTERVENTION GROUP 1 - Early and frequent nutrition support via telephone
WHY
To deliver appropriate nutritional support and advice as soon as practicable following diagnosis.

WHAT
Participants randomised to the telephone intervention group will need regular access to a telephone. Nutrition advice and support will be provided over the phone and tailored to each participant that is, in part, informed by the treatment pathway planned by the multidisciplinary team treating the participant, and also by the needs of the participant throughout the study period. Nutrition information fact sheets will be available to participants which describe strategies for managing nutrition impact symptoms associated with disease progression and treatment side effects (e.g managing fatigue, nausea, vomiting). Information/resources will be posted via mail or email to the participant. Participants will also be provided with forms to order oral nutrition supplements if deemed relevant.

All participants will continue to receive usual nutrition care provided by their health service. For those randomised to an intervention group, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis.

PROVIDED BY
The intervention will be provided by a research dietitian who has experience working with the upper gastrointestinal cancer population and is skilled in using behaviour change techniques.

HOW
The early and frequent nutrition support/ advice will be delivered to individual participants by telephone.

WHERE
The intervention delivery occurs wherever the participant chooses to be provided they have access to a telephone including their home, holiday destination, at hospital, etc..

WHEN and HOW MUCH
* Initial contact within first week from date of recruitment.
* First follow-up within first week after initial contact.
* Fortnightly contact (15 -30 minutes) thereafter for general check-ups or more frequent at discretion of treating dietitian over a period of 18 weeks.
* Email contact can replace phone call for fortnightly follow-up if the next scheduled session is not a pre-specified goal review.

TAILORING
Individual nutrition support/ advice will be provided. Participants’ needs will vary depending on the tumour location, the treatment pathway, nutrition impact symptoms and treatment side effects experienced. Participants will set weekly goals aimed at promoting nutritional intake.

HOW WELL
Adherence and fidelity will be assessed by 1) recording the number and duration of telephone calls between the research dietitian and participant during the 18 week intervention period; 2) a record of the behaviour change techniques used by the research dietitian (according to Behaviour Change Technique Taxonomy (v1) (Michie et al, Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6).

INTERVENTION GROUP 2 - Early and frequent nutrition support via mobile application
WHY
The purpose of the mobile application intervention group is to deliver appropriate nutritional support and advice as soon as practicable following diagnosis.
WHAT
Participants randomised to the intervention group will be provided with an iPad and mobile sim card that has an internet-enabled application downloaded (myPace) to facilitate communication between the research dietitian and the participants in this group. Participants may choose to use their own iPad or smartphone and download the myPace application. Nutrition advice and support will be tailored to each participant that is, in part, informed by the treatment pathway planned by the multidisciplinary team treating the participant, and also by the needs of the participant throughout the study period. Nutrition information fact sheets will be available to participants which describe strategies for managing nutrition impact symptoms associated with disease progression and treatment side effects (e.g managing fatigue, nausea, vomiting). The mobile application can be used for email and text message communication, and can save and store these messages along with resources provided to the participant. Participants will also be provided with forms to order oral nutrition supplements if deemed relevant.

All participants will continue to receive usual nutrition care provided by their health service. For those randomised to an intervention group, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. The participants in the mobile application group will be able to access the application up to week 26, however tailored nutrition support will not be available beyond 18 weeks.

PROVIDED BY
The intervention will be provided by a research dietitian who has experience working with the upper gastrointestinal cancer population and is skilled in using behaviour change techniques.

HOW
The early and frequent nutrition support/ advice will be delivered to individual participants by mobile application (myPace).

WHERE
The intervention delivery occurs wherever the participant chooses to be provided they have access to an internet connection, including their home, holiday destination, at hospital etc.

WHEN and HOW MUCH
* Initial contact within first week from date of recruitment.
* First follow-up within first week after initial contact.
* Fortnightly contact (15 -30 minutes) thereafter for general check-ups or more frequent at discretion of treating dietitian over a period of 18 weeks.

TAILORING
Individual nutrition support/ advice will be provided. Participants’ needs will vary depending on the tumour location, the treatment pathway, nutrition impact symptoms and treatment side effects experienced. Participants will set weekly goals aimed at promoting nutritional intake.

HOW WELL
Adherence and fidelity will be assessed by 1) recording the number of electronic messages exhanged between the research dietitian and participant and the time lapse between responses (i.e participant to reply to research dietitan; and research dietitan to reply to participant) during the 18 week intervention period; 2) a record of the behaviour change techniques used by the research dietitian (according to Behaviour Change Technique Taxonomy (v1) (Michie et al, Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6).
Intervention code [1] 296078 0
Lifestyle
Intervention code [2] 296975 0
Treatment: Other
Comparator / control treatment
Control group participants will receive usual care. This is generally a referral-based system for access to dietetic services. Upon referral to a dietitian, a range of strategies to assess and provide the participant with nutritional care will be employed. This usually occccurs when a patient is admitted to hospital and the referral is clinically indicated. Communication with the dietitan is generally face-to-face.
Control group
Active

Outcomes
Primary outcome [1] 299826 0
Quality adjusted life years across a 12 month follow up period, An area under the curve approach will be used to calculate quality adjusted life years for each participant using EQ-5D-5L data collected.
Timepoint [1] 299826 0
Baseline, 3 month, 6month, 12 month follow up assessments.
Secondary outcome [1] 328209 0
EQ-5D-5L Global Health Visual Analog Scale
Timepoint [1] 328209 0
Baseline, 3 month, 6 month, and 12 month.
Secondary outcome [2] 328210 0
EORTC QLQ-C30. This scale has the individual domain scores of global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. Each domain will be compared between groups individually.
Timepoint [2] 328210 0
Data collected at baseline, 3 months, 6 months and 12 months
Secondary outcome [3] 328211 0
Direct health care costs captured from Medicare Australia databse, Pharmaceutical Benefits Scheme database, hospital administration database, participant self report, and research personnel recording costs of delivery of the intervention.
Timepoint [3] 328211 0
Costs will be collected over the 12 month follow up preiod.
Secondary outcome [4] 328212 0
Indirect/ productivity costs captured using the Health and Labour Questionnaire.
Timepoint [4] 328212 0
This survey will be applied at baseline, 3, 6 and 12 months.
Secondary outcome [5] 328214 0
Time from baseline until death.
Timepoint [5] 328214 0
Over the 12 month follow up period.
Secondary outcome [6] 328215 0
Body weight
Timepoint [6] 328215 0
Will be collected at baseline, 3, 6 and 12 months.
Secondary outcome [7] 329595 0
Hand grip strength will be measured using a hand dynamometer if participants are an inpatient or attending an outpatient clinic at the time of data collection. If participants are at home at the time of data collection, the only secondary outcomes that will be obtained are those that can be completed remotely.
Timepoint [7] 329595 0
Baseline and +/- one week of follow up at baseline, 3, 6 and 12 months.

Secondary outcome [8] 329596 0
CT scans to determine body composition (visceral fat)
Timepoint [8] 329596 0
Where available from patient records where it coincides with planned follow up periods (baseline, 3, 6, 12 months).
Secondary outcome [9] 329597 0
Nutritional status will be assessed using the Patient-generated Subjective Global Assessment.
Timepoint [9] 329597 0
Basliene, 3 months, 6 months, 12 months.
Secondary outcome [10] 329922 0
Waist circumference
Timepoint [10] 329922 0
Baseline, 3 months, 6 months, 12 months

Eligibility
Key inclusion criteria
1. Primary new diagnosis of oesophageal or stomach or pancreatic cancer
2. Not receiving end of life care
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Insufficient knowledge of English language to be able to consent
2 Unable to provide informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered sealed opaque envelopes will be held by one person who is not involved in data collection. The blinded recruiter/ baseline data collector will contact the project manager after baseline measures are completed. the project manager will reveal the allocation to the research dietitian.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization. Stratification (2 groups) will be based on Malnutrition Screening Tool (MST) score of <3 or =/>3.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features


Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary outcome:
EQ-5D-5L utility score
We will calculate the number of Quality Adjusted Life Years (QALY) lived over the follow up period using an area under the curve (AUC) approach for each participant. The number of QALY lived will be compared between groups using linear regression analyses with adjustment for baseline level of utility.

Adjustment will be made statisticaly for cancer location as a covariate (oesophageal upper gastric, lower gastric, pancreatic).

Secondary outcomes
Survival time will be compared between groups using Cox proportional hazards regression analysis.

All other secondary outcomes will be compared between groups using linear mixed models analyses. Treatment group will be entered as a fixed factor and participants and assessment points as random factors. Individual assessments will be nested within participants. Adjustment will be made for baseline values of the relevant secondary outcome and for cancer location as a covariate (oesophageal upper gastric, lower gastric, pancreatic).

Exploratory analyses will be undertaken to identify potential intervention interaction effects with age, confidence to use and pre-existing use of iPad/smart phone.



Recruitment
Recruitment status
Active, not recruiting
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)
VIC

Funding & Sponsors
Funding source category [1] 295119 0
Government body
Name [1] 295119 0
Victorian Cancer Agency
Address [1] 295119 0
50 Lonsdale St, Melbourne
VIC

Postal:
GPO Box 4057 (Level 15)
MELBOURNE VIC 3001
Country [1] 295119 0
Australia
Primary sponsor type
Individual
Name
Professor Terry Haines
Address
Kingston Centre
400 Warrigal Road
Cheltenham VIC 3192
Country
Australia
Secondary sponsor category [1] 293939 0
Hospital
Name [1] 293939 0
Monash Health
Address [1] 293939 0
246 Clayton Road
Clayton
Victoria 3168
Country [1] 293939 0
Australia
Secondary sponsor category [2] 293940 0
Hospital
Name [2] 293940 0
Monash University
Address [2] 293940 0
Be Active Sleep Eat Facility
Monash University
1/264 Ferntree Gully Road
Notting Hill 3168
Victoria
Country [2] 293940 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296471 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 296471 0
Research Support Services
Monash Health
Monash Medical Centre
246 Clayton Rd
Clayton, VICTORIA 3168
Ethics committee country [1] 296471 0
Australia
Date submitted for ethics approval [1] 296471 0
01/09/2016
Approval date [1] 296471 0
14/10/2016
Ethics approval number [1] 296471 0
HREC/16/MonH/290 RES-16-0000434A

Summary
Brief summary
The aim of this study is to examine whether very early dietetic intervention for people with newly diagnosed upper gastrointestinal cancer will enhance quality adjusted life years lived compared with usual dietetic care.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have primary new diagnosis of oesophageal or stomach or pancreatic cancer.

Study details
Participants will be randomised (allocated by chance) to one of three treatment groups (usual care, early intervention telephone or early intervention electronic messages via mobile application). For those randomised to intervention groups, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. Personalised nutrition support/ advice will be provided. Outcomes will be measured at baseline and at follow up at 3, 6 and 12 months.
It is hoped that this study will demonstrate effectiveness of early and frequent dietetic intervention in enhancing quality of life and that intervention will be cost-effective while also minimising nutritional decline (weight loss).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69494 0
Prof Terry Haines
Address 69494 0
Room 304
Building G
Peninsula Campus, Monash University
McMahons Road
Frankston Victoria 3199
Country 69494 0
Australia
Phone 69494 0
+61 3 9902 9409
Fax 69494 0
Email 69494 0
terrence.haines@monash.edu
Contact person for public queries
Name 69495 0
Dr Kate Huggins
Address 69495 0
Monash University
Be Active Sleep Eat facility
Level 1
264 Ferntree Gully Rd
Notting Hill 3168
VIC
Country 69495 0
Australia
Phone 69495 0
+61 3 9902 4269
Fax 69495 0
Email 69495 0
Kate.Huggins@monash.edu
Contact person for scientific queries
Name 69496 0
Prof Terry Haines
Address 69496 0
Room 304

Building G

Peninsula Campus, Monash University

McMahons Road

Frankston Victoria 3199
Country 69496 0
Australia
Phone 69496 0
+61 3 9902 9409
Fax 69496 0
Email 69496 0
terrence.haines@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
After all planned papers are published and PhD Theses submitted and passed. No end date determined
Available to whom?
Only researchers who provide a methodologically sound proposal
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
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1937 0
Study protocol
Citation [1] 1937 0
Link [1] 1937 0
Email [1] 1937 0
Other [1] 1937 0
https://doi.org/10.1186/s12885-018-4595-z
Attachment [1] 1937 0
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?
Results – basic reporting
Results – plain English summary