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Trial registered on ANZCTR


Registration number
ACTRN12624000084583
Ethics application status
Approved
Date submitted
20/12/2023
Date registered
31/01/2024
Date last updated
5/06/2024
Date data sharing statement initially provided
31/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can dietitian-led intensive telehealth support to maximise nutritional intake through dietary strategies, symptom management and the option for 'top-up' small bowel tube feeding improve quality of life in patients with pancreatic cancer?
Scientific title
Assessing the impact of an intensive dietitian-led telehealth intervention focusing on nutritional adequacy and symptom control, on quality of life in patients with pancreatic cancer: a randomised controlled trial
Secondary ID [1] 311195 0
None
Universal Trial Number (UTN)
Trial acronym
SuperQoL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 332373 0
Condition category
Condition code
Cancer 329082 329082 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive nutrition intervention delivered via telehealth, including nutrition counselling, education, symptom management, as well as oral nutrition support +/- supplemental jejunal feeding.

WHY
To deliver appropriate nutritional support, advice, and symptom management to people with pancreatic cancer undergoing chemotherapy treatment.

WHAT
Participants randomised to the intervention group will receive dietetic counselling, education, oral nutrition support +/- supplemental jejunal feeding combined with proactive nutrition impact symptom pharmacological management delivered at least weekly via phone or video telehealth for the 6-month trial period. Participants will need regular access to a telephone or computer/smart phone with a camera. Participants who opt to receive supplemental enteral feeding will be given via percutaneous endoscopic or radiologically inserted gastrostomy tube with a jejunal extension (PEG-J or RIG-J) or nasojejunal tube (NJT) via endoscopy or radiology as a day procedure. Feeding regimens will be individualised to meet participants’ specific energy and protein needs, titrated up or down depending on oral energy and protein intake. A participant information pack (designed specifically for the study) will be available to participants, which describes standard, evidence-based practice strategies for managing nutrition impact symptoms (both dietary and medication), and key enteral feeding information (e.g., feed administration, stoma site care, useful contacts etc.). At study commencement, participants will be given baseline prescriptions for antiemetics (metoclopramide 10mg, ondansetron 8mg) and pancreatic enzyme replacement therapy (PERT) (Creon, 25,000IU) to ensure proactive nutrition impact symptom management is feasible. If they require additional medications their treating oncology team can provide this, or the intervention dietitian will liaise (phone or email) with the treating team to provide recommendations. Additional information/resources given to participants during the trial will be sent via email or post. Once the 6-month intervention period has ended, participants with enteral feeding tubes will have these removed. However, if the participant chooses and it is medically appropriate, they may retain the PEG-J/RIG-J/NJT. All participants will have their nutrition care handed over to the dietitian service at their treating health service following the conclusion of the intervention.

PROVIDED BY
The intervention will be provided by research dietitians who have experience working with the pancreatic cancer population and home enteral nutrition.

HOW
The dietetic counselling, education, oral nutrition support and pharmacologic nutrition impact symptom management will be delivered via telehealth (phone or video). Feeding tubes will be inserted as a day procedure in hospital.

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

WHEN and HOW MUCH
* Initial nutrition assessment to be completed by the intervention dietitian after randomisation via telehealth for approximately 60 minutes.
* The next contact will be weekly consults (at minimum), with the intervention dietitian via telehealth (phone/video) for the duration of the study intervention period (6-months). Participants may also contact the dietitian via telehealth.
*Individualised nutrition support/advice will be provided. Participants’ needs will vary depending on the chemotherapy regimen and nutrition impact symptoms experienced. There will be a standard operating procedure to ensure standardisation. This will ensure a framework for intervention delivery between participants.

For those who opt to receive an enteral feeding tube:
* Feeding tube insertion will occur as a day procedure. For patients who have undergone any cycles of chemotherapy, enteral tube insertion will only occur if their serum neutrophil level is within the reference range of 1.5-8 x 10^9/l.
* As soon as practicable after the feeding tube is inserted, the participant will be visited in their home for training and education on using and caring for the feeding tube.

Intervention fidelity will be assessed by:
- Number and duration of telehealth contacts between the intervention dietitian and participant during the 6-month intervention period;
- Behaviour change techniques used by the intervention dietitian (according to Behaviour Change Technique Taxonomy (v1) (Michie et al, DOI: 10.1007/s12160-013-9486-6). (e.g. goal setting, review of goal setting, self-monitoring of behaviour, problem solving, information on health consequences).
- Adherence to PEG-J/RIG-J/NJT insertion procedures, presence and frequency of infections and other complications;
- Adherence to intervention dietitian recommendations for dosing and timing of pancreatic enzyme replacement therapy (PERT);
- Medical practitioner uptake of intervention dietitian recommendations for medication and prescribing;
- Participant adherence to the oral nutrition support/enteral feeding regimen recommended by the intervention dietitian.


Intervention code [1] 327642 0
Treatment: Other
Intervention code [2] 327643 0
Behaviour
Comparator / control treatment
Participants in the control group will receive usual nutrition care. This most commonly involves nutrition screening at each chemotherapy visit, and consultations with an oncology dietitian at chemotherapy day units during treatment, where clinically indicated.
Control group
Active

Outcomes
Primary outcome [1] 336900 0
Quality of life
Timepoint [1] 336900 0
Baseline, 3-months, 6-months post randomisation (primary timepoint)
Secondary outcome [1] 430080 0
Quality of life
Timepoint [1] 430080 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [2] 430081 0
Overall survival
Timepoint [2] 430081 0
Between baseline and 12-months post randomisation
Secondary outcome [3] 430082 0
Malnutrition risk
Timepoint [3] 430082 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [4] 430083 0
Malnutrition presence and severity
Timepoint [4] 430083 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [5] 430084 0
Change in body weight
Timepoint [5] 430084 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [6] 430085 0
Skeletal muscle strength
Timepoint [6] 430085 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [7] 430088 0
Skeletal muscle mass
Timepoint [7] 430088 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [8] 430091 0
Exploratory outcome: Skeletal muscle mass
Timepoint [8] 430091 0
Where available from patient records when it coincides with planned baseline or follow up assessments (baseline, 3 months, 6 months post randomisation)
Secondary outcome [9] 430093 0
Exploratory outcome: Skeletal muscle mass
Timepoint [9] 430093 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [10] 430094 0
Intervention fidelity
Timepoint [10] 430094 0
Between baseline and 6-months post randomisation
Secondary outcome [11] 430098 0
Economic evaluation
Timepoint [11] 430098 0
Baseline to 6-months post randomisation
Secondary outcome [12] 430102 0
Changes in chemotherapy dosing
Timepoint [12] 430102 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [13] 430796 0
Quality of life
Timepoint [13] 430796 0
Baseline, 3-months, 6-months post randomisation
Secondary outcome [14] 430797 0
Weight change
Timepoint [14] 430797 0
Baseline, 3-months and 6-months post randomisation
Secondary outcome [15] 430798 0
Exploratory outcome: Skeletal muscle quality (fatty infiltration)
Timepoint [15] 430798 0
Where available from patient records when it coincides with planned baseline or follow up assessments (baseline, 3 months, 6 months post randomisation)
Secondary outcome [16] 430799 0
Exploratory outcome: Skeletal muscle quality (fatty infiltration)
Timepoint [16] 430799 0
Baseline, 3-months, 6-months post randomisation

Eligibility
Key inclusion criteria
1. At least 18 years of age at time of screening
2. Ability to provide informed consent and willing to comply with study procedures (i.e. completion of study outcome questionnaires, participation in intervention if randomised to intervention group)
3. New diagnosis of borderline resectable, locally advanced or metastatic pancreatic cancer commencing chemotherapy
4. Life expectancy of at least 6 months from the time of screening as judged by the patient's health care team
5. ECOG performance status score of less than or equal to 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with neuroendocrine pancreatic cancers
2. Patients who have previously had a pancreatic cancer surgical resection
3. Patients who have received 2 or more cycles of chemotherapy for PC
4. Patients with serious medical or psychiatric conditions that might compromise protocol-based management as judged by the patient's treating healthcare team
5. Patients receiving ‘end of life’ care
6. Patients who declined or are deemed unsuitable for systemic chemotherapy
7. Patients with insufficient cognition to provide consent as judged by the patient's treating healthcare team
8. Patients with insufficient knowledge of the English language who do not have a family member that can assist with English translation to facilitate completion of outcome data collection, or interviews with the study dietitian

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)
The random allocation sequence will be developed by a statistician who has no role in the recruitment of participants or data collection. A project team member will contact the research assistant and provide the sequential participant trial registration number. The intervention dietitian will contact the participant via phone to advise them of their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic randomisation methods will be employed based upon a malnutrition risk (PG-SGA Short Form) (dichotomous) baseline assessment, cancer stage, and commencement of chemotherapy (Y/N), which will all be scored.
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
Safety/efficacy
Statistical methods / analysis
The sample size will be n = 41 participants per group. A two-group comparison power analysis using the primary outcome, a power of 80%, and two-tailed alpha of 0.05 was undertaken. We considered that the minimum standard effect that would be needed to justify the invasiveness of the procedure, cost of procedure and likely cost of using supplements and giving equipment would be a delta of 0.50 (large effect). In absolute terms, this is change of 0.15 in health utility (scale value of 1 = perfect health, value of 0 = death) given a standard deviation in our previous study data of 0.29 for health utility at baseline (PMID 35956410). With these inputs and considering including of a baseline measurement and two follow-up measurements (3 and 6 months) with correlation between them of 0.41 (based on previous study data) in the model, we calculated that we would need n = 34 participants per group. We increased this requirement by 20% to n = 41 per group to account for attrition and/or missing data.

Analyses will be undertaken on an intention-to-treat basis. The primary outcome (the EORTC QLQ-C30 Summary Score) will be compared between groups using a linear mixed model analysis approach, using values collected at three and six months. These analyses will be adjusted for the baseline values of this variable, as well as age, sex, cancer stage, and malnutrition risk score (PGSGA Short Form score). Group allocation will be treated as a fixed effect, while a random intercept will be used for individual participants. We will conduct relevant checks of distributional assumptions and model fit. Twelve-month mortality will be compared between groups using Cox Proportional Hazards regression analyses, adjusting for baseline values of health-related quality of life (EORTC QLQ-C30 Summary Score), as well as age, sex, cancer stage, and malnutrition risk score (PGSGA Short Form score). Multiple imputation will be used in the event of missing data with checking or relevant assumptions for missing-ness to inform the final imputation approach.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315458 0
Government body
Name [1] 315458 0
Medical Research Future Fund (MRFF), Grant number MRF2023522
Country [1] 315458 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 317527 0
None
Name [1] 317527 0
Address [1] 317527 0
Country [1] 317527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314363 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 314363 0
246 Clayton Road, Clayton VIC 3168
Ethics committee country [1] 314363 0
Australia
Date submitted for ethics approval [1] 314363 0
23/08/2023
Approval date [1] 314363 0
12/12/2023
Ethics approval number [1] 314363 0
HREC/94831/MonH-2023-389590(v1)

Summary
Brief summary
The aim of this study is to examine whether intensive telehealth dietetic counselling, education, proactive medication management of nutrition impact symptoms, oral nutrition support +/- supplemental ('top-up') tube feeding into the small bowel will enhance quality of life for people with borderline resectable and inoperable pancreatic cancer having palliative chemotherapy, compared with usual care.

Who is it for?
Participants may be eligible to join this study if they are aged 18 years or above and have a new primary diagnosis of borderline resectable or inoperable pancreatic cancer.

Participants will be randomised (allocated by chance) to one of two groups: usual care or intensive dietetics intervention (counselling, education, symptom management, oral nutrition support, +/- jejunal tube feeding if participant chooses) delivered via telehealth. For those randomised to intervention group, participants will receive the active intervention for 6-months, 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 and 6 months.
It is hypothesised that this study will demonstrate effectiveness of early and frequent dietetic intervention and supplemental jejunal feeding (when required), in enhancing quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131322 0
Dr Daniel Croagh
Address 131322 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 131322 0
Australia
Phone 131322 0
+61 395946666
Fax 131322 0
Email 131322 0
daniel.croagh@monashhealth.org
Contact person for public queries
Name 131323 0
Dr Lauren Hanna
Address 131323 0
Monash University Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 131323 0
Australia
Phone 131323 0
+61 399024270
Fax 131323 0
Email 131323 0
lauren.hanna@monash.edu
Contact person for scientific queries
Name 131324 0
Dr Kate Furness
Address 131324 0
Department of Sport, Exercise and Nutrition Sciences, La Trobe University Bundoora, VIC 3086
Country 131324 0
Australia
Phone 131324 0
+61 394796556
Fax 131324 0
Email 131324 0
kate.furness@latrobe.edu.au

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 and evidence of ethics approval.
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 (email daniel.croagh@monashhealth.org)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21231Study protocol    Via formal written request to principal chief inve... [More Details]



Results publications and other study-related documents

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