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Trial registered on ANZCTR


Registration number
ACTRN12613000320752
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
21/03/2013
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Eating As Treatment (EAT): A stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy
Scientific title
Eating as treatment (EAT): a stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy
Secondary ID [1] 282118 0
NIL
Universal Trial Number (UTN)
U1111-1137-6830
Trial acronym
EAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer Patients Undergoing Radiotherapy 288611 0
Depression 288612 0
Condition category
Condition code
Cancer 288944 288944 0 0
Head and neck
Diet and Nutrition 288945 288945 0 0
Other diet and nutrition disorders
Mental Health 288946 288946 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study is a stepped wedge, randomised controlled trial, whereby each site undergoes a control period (varying in duration from 4 to 16 months) followed by training (consisting of a two day workshop and a one day clinic visit) and then an intervention period (varying in duration from 4 to 16 months).

Intervention

EAT is a behaviour change counselling intervention based on the strategy delivered by Dr Britton in the pilot study [publication in development]. It has been refined to be delivered by dietitians in the clinical setting, alongside their normal dietetic involvement with HNC patients (i.e. weekly during radiotherapy, fortnightly for six weeks post-radiotherapy and then 'as needed' thereafter).

It is largely based on motivational interviewing (MI) and cognitive behavioural therapy (CBT) strategies. EAT is designed to improve health behaviours of HNC patients and maintain their nutrition over the course of their cancer treatment. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube. Although to a healthy population this may seem a simple task, in order for HNC patients to eat, they must overcome significant barriers of pain, oral disfigurement, mucositis, nausea, reduced or no saliva, taste changes and severe losses of appetite in addition to the premorbid complications of high rates of alcohol misuse, mental illness and poorer self-care. EAT is designed to assist the HNC patient in finding the motivation to eat despite all these barriers, and to provide them with practical behaviour change strategies to support this change.

Training will be delivered in a two-day workshop. On the day after training, the trainers will accompany dietitians during their usual consultations to assist with the clinical implementation of EAT. The trainers will return in two months to refresh EAT intervention skills, problem solve clinical concerns and troubleshoot any systems change issues that may have arisen.

During the intervention phase, dietitians will participate in at least monthly supervision with one of the trainers (clinical psychologist). Supervision will be used to discuss clinical issues, problem solve and provide skills based feedback. Common themes, barriers and solutions discussed during supervision will be distributed (e.g. email) to participating dietitians.

Systems change strategies will be used to encourage the implementation of EAT and, as appropriate, to align dietetic practice with clinical guidelines. This element of the study is aimed at positioning dietetic intervention and counselling as an integral part of cancer care. The following elements will be addressed with staff during training.

1. Due to the prevalence of depression amongst HNC patients, dietitians will be trained in a method used to screen for symptoms of depression (PHQ-2). For patients who are identified to be at risk of depression, dietitians will be encouraged to work with radiation oncologists to implement a referral procedure. This procedure will be site specific and developed in close consultation with hospital staff. Dietitians will be asked to document in client notes when the PHQ-2 is administered and the outcome (i.e. whether the patient was referred to the radiation oncologist). Radiation oncologists will be asked to document in client notes what support option(s) were discussed with the patient and whether a referral was made.

2. Dietitians will be asked to consult with patients in accordance with the schedule documented within the clinical guidelines (weekly during radiotherapy, fortnightly for six weeks post treatment and ‘as required’ thereafter). Dietitians will be asked to document the occurrence of each dietetic consultation within client notes.

3. Sites will be asked to schedule dietetic appointments adjacent to radiotherapy appointments. Integrating dietetics into radiotherapy in this way is designed to position dietetic intervention as an integral part of cancer care for both patients and department staff.

4. To prompt the delivery of dietetic intervention consistent with the intervention/guidelines, the medical records of patients will include a coloured printed prompt, placed by research staff, identifying the patient as a trial participant, outlining the key components of dietetic intervention and the behavioural change techniques recommended for use during the consultation.
Intervention code [1] 286721 0
Treatment: Other
Intervention code [2] 286722 0
Behaviour
Comparator / control treatment
Treatment as Usual
During the control period, all participants will receive treatment as usual by trained dietitians according to standard hospital practice. The duration of the control period will vary from approximately 4 to 16 months.
Control group
Active

Outcomes
Primary outcome [1] 289072 0
Patient-Generated Subjective Global Assessment (PGSGA)
Timepoint [1] 289072 0
Week one radiotherapy;
Final week of radiotherapy;
Four weeks post radiotherapy;
Twelve weeks post radiotherapy
Secondary outcome [1] 301676 0
Radiotherapy treatment completion; Chart Review & Chart Audit
Timepoint [1] 301676 0
12 Weeks Post Radiotherapy
Secondary outcome [2] 301677 0
Total radiotherapy treatment time ; Chart Review & Chart Audit
Timepoint [2] 301677 0
12 weeks post radiotherapy
Secondary outcome [3] 301678 0
Unplanned hospital visits; Chart Review & Chart Audit
Timepoint [3] 301678 0
12 weeks post radiotherapy
Secondary outcome [4] 301679 0
Length of unplanned admissions; Chart Review & Chart Audit
Timepoint [4] 301679 0
12 weeks post radiotherapy
Secondary outcome [5] 301680 0
Dietitian contact (number and frequency); Chart Review & Chart Audit
Timepoint [5] 301680 0
12 weeks post radiotherapy
Secondary outcome [6] 301681 0
Referral to appropriate services for depression; Chart Review
Timepoint [6] 301681 0
12 weeks post radiotherapy
Secondary outcome [7] 301682 0
Self-reported depression; Patient Health Questionnaire 9 (PHQ9)
Timepoint [7] 301682 0
Week one of radiotherapy
Final week of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [8] 301683 0
Therapeutic Alliance; Agnew Relationship Measure – Five Item Version (ARM-5) - Dietitian and Patient versions
Timepoint [8] 301683 0
Week one of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [9] 301684 0
Self reported nicotine dependence; Fagerstrom Test for Nicotine Dependence (FTND)
Timepoint [9] 301684 0
Week one of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [10] 301685 0
Biochemical verification of smoking status (Expired carbon monoxide)
Timepoint [10] 301685 0
Week one of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [11] 301686 0
Self-reported alcohol dependence; Alcohol Use Disorders Identification Test (AUDIT);
Timepoint [11] 301686 0
Week one of radiotherapy
Secondary outcome [12] 301687 0
Self-reported alcohol consumption; Q1-3 AUDIT
Timepoint [12] 301687 0
Week one of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [13] 301688 0
Dysphagia; Common Terminology Criteria for Adverse Events (CTCAE)
Timepoint [13] 301688 0
Week one of radiotherapy
Final week of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [14] 301689 0
Dysphagia (Australian Standard of Food Texture)
Timepoint [14] 301689 0
Week one of radiotherapy
Final week of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [15] 301690 0
Mucositis; Common Terminology Criteria for Adverse Events (CTCAE)
Timepoint [15] 301690 0
Week one of radiotherapy
Final week of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [16] 301691 0
Quality of Life; European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Timepoint [16] 301691 0
Week one of radiotherapy
Final week of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [17] 301692 0
Quality Adjusted Life Years; Quality of Life; European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Timepoint [17] 301692 0
Week one of radiotherapy
Final week of radiotherapy
Four weeks post radiotherapy
Twelve weeks post radiotherapy
Secondary outcome [18] 301693 0
Patient Health Questionnaire – two item version (PHQ2);
Timepoint [18] 301693 0
Week one of radiotherapy - intervention phase only
Secondary outcome [19] 301694 0
Tumour Site, Stage and Response; Chart Review & Chart Audit
Timepoint [19] 301694 0
12 weeks post radiotherapy
Secondary outcome [20] 301695 0
Mortality; Chart Audit
Timepoint [20] 301695 0
12 weeks post radiotherapy

Eligibility
Key inclusion criteria
Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx requiring definitive or postoperative radiotherapy with curative intent

Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)

Receiving a prescribed dose of at least 60 Gy

Definitive or post operative adjuvant Radiotherapy intent permitted

Radiotherapy as sole modality or Chemoradiation (including neoadjuvant and adjuvant chemotherapy) permitted

Participation of patients on other clinical trial protocols permitted provided these trials are likely to continue throughout the period of this study. This will ensure that patients in both the control and intervention group are exposed to similar radiotherapy treatments.

> 18 years of age

Available for follow-up for at least 6 months

Life expectancy greater than 6 months

Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient not meeting the eligibility criteria

Patient cannot communicate in English

Patient with organic brain diseases impairing ability to complete questionnaires satisfactorily

Patients where significant oral or pharyngeal mucositis is not expected as a complication of radiotherapy treatment (patients with T1 / T2 glottic carcinoma undergoing small field radiotherapy or T1/T2 tonsil cancer undergoing unilateral treatment are not eligible)

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)
This is a stepped wedge design. Therefore all hospitals will begin in the control condition and at a randomly generated point in time will receive training and begin delivering the intervention. Randomisation will be used to guide the order in which hospitals will receive training AND to guide patient enrolment.

Due to the nature of a stepped wedge design, enrolment into the trial will occur at a rate of approximately one participant per site, per week for the duration of the trial.

On a weekly basis, research officers will be required to use treatment planning software (i.e. VARIAN or MOSAIQ) or similar to generate a list of patients who meet the following criteria:
1. Aged 18+
2. Have one or more of the following cancer diagnoses
a. Nasopharynx
b. Oropharynx
c. Oral Cavity
d. Larynx
e. Hypopharynx
3. Scheduled to undergo definitive or postoperative radiotherapy

Once a list has been generated of patients meeting the above screening criteria, data managers/ trial coordinators will be required to use an online system to randomise the order in which patients will be approached regarding consent.

This system will indicate which order patients should be approached with information about the study, with a view toward enrolment.

The research officer will approach patients with information about the study in the order generated until the weekly enrolment target has been met.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which hospitals will be randomised will be done by an independent statistician not involved with the study. The statistician will be sent the list of hospitals and asked to use the uniform randomisation function in the statistical package of their choice to order the hospitals from 1 to 5. The function will use time as the seed and the order of randomisation of hospitals from first to last will be the same as the order from 1 to 5 as determined by the statistician.

Randomisation software will be used to generate the randomised 'approach order' for patient enrolment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
The current trial is a stepped wedge cluster randomised control trial. In a stepped wedge design all hospitals begin in the control condition and then move to the intervention condition at randomised intervals. During the control phase, all patients will receive 'treatment as usual'. At randomised intervals across the study, researchers will travel to hospital sites to provide dietitians with training in the EAT intervention. Following training, all patients will receive 'intervention'. Assessments will be conducted on a sample of patients (N=400) recruited across the control and intervention phases of the study. A randomisation procedure will be used to guide enrolment into the study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary endpoint for this study is nutritional status at 12 weeks post treatment as measured by the PG-SGA. Differences in the mean level of PG-SGA from before to after the introduction of the intervention will be tested using ANalysis of COVAriance (ANCOVA). The outcome in the model will be the individuals PG-SGA score at 12 weeks and their baseline value of PG-SGA will be included as a covariate. We expect the intervention in this study to have an instantaneous impact on the health of patients and therefore we expect a sudden shift in the mean level of PG-SGA after the intervention is introduced. We will include a before and after intervention term in the model and it will be the p-value associated with the before and after term that will be used to determine whether there is a statistically significant improvement in PG-SGA scores as a result of the intervention. The model will also include terms for hospital and time, with time measured as months since study onset.

A detailed Statistical Analysis Plan (SAP) will be developed prior to the implementation of the intervention in the second hospital.

Recruitment
Recruitment status
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)
QLD,SA,WA,VIC
Recruitment hospital [1] 739 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 740 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 741 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 745 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 746 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [6] 2414 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [7] 2415 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 8052 0
4350 - Toowoomba
Recruitment postcode(s) [2] 8053 0
4350 - Rockville
Recruitment postcode(s) [3] 8054 0
6009 - Nedlands
Recruitment postcode(s) [4] 8055 0
3002 - East Melbourne
Recruitment postcode(s) [5] 8056 0
5000 - Adelaide
Recruitment postcode(s) [6] 8057 0
4101 - South Brisbane
Recruitment postcode(s) [7] 8058 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 286888 0
Government body
Name [1] 286888 0
National Health & Medical Research Council
Address [1] 286888 0
NHMRC, 16 Marcus Clarke St, City West, Canberra, ACT 2601
Country [1] 286888 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Professor Amanda Baker, School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 285676 0
None
Name [1] 285676 0
Address [1] 285676 0
Country [1] 285676 0
Other collaborator category [1] 277320 0
Other Collaborative groups
Name [1] 277320 0
TransTasman Radiation Oncology Group (TROG)
Address [1] 277320 0
TROG CENTRAL OPERATIONS OFFICE
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7, Hunter Region Mail Centre
NSW 2310
Country [1] 277320 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288947 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288947 0
HNEHREC, Locked Bag No 1, New Lambton, NSW, 2305
Ethics committee country [1] 288947 0
Australia
Date submitted for ethics approval [1] 288947 0
30/03/2012
Approval date [1] 288947 0
09/05/2012
Ethics approval number [1] 288947 0
HNEHREC: 12/04/18/4.06; NSW HREC: HREC/12/HNE/108
Ethics committee name [2] 288950 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 288950 0
Human Research Ethics Administration
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 288950 0
Australia
Date submitted for ethics approval [2] 288950 0
18/05/2012
Approval date [2] 288950 0
22/05/2012
Ethics approval number [2] 288950 0
H-2012-0150
Ethics committee name [3] 288951 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [3] 288951 0
Level 2 A Block
Hospital Ave
Nedlands
WA 6009
Ethics committee country [3] 288951 0
Australia
Date submitted for ethics approval [3] 288951 0
28/08/2012
Approval date [3] 288951 0
14/11/2012
Ethics approval number [3] 288951 0
2012-136
Ethics committee name [4] 288952 0
Royal Adelaide Hospital HREC
Ethics committee address [4] 288952 0
Hanson Institute
Frome Road
Adelaide
SA 5000
Ethics committee country [4] 288952 0
Australia
Date submitted for ethics approval [4] 288952 0
06/03/2013
Approval date [4] 288952 0
Ethics approval number [4] 288952 0
HREC/12/HNE/108

Summary
Brief summary
This study is evaluating the effectiveness of a dietitian delivered health behaviour intervention to reduce malnutrition in head and neck cancer patients undergoing radiotherapy.

Who is it for?

This study is taking place within six Australian Hospitals. You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of cancer involving the nasopharynx, oropharynx, oral cavity, larynx, or hypopharynx requiring definitive or postoperative radiotherapy with curative intent.

Trial details

All sites will begin in the ‘control’ condition – dietitians will provide ‘treatment as usual’. Participants recruited during this phase will receive treatment as usual by trained dietitians according to standard hospital practice. At a randomly determined time point, researchers will attend the hospitals to provide training to the dietitians. Dietitians will then provide ‘EAT’ (Eating as Treatment) as part of standard dietetic consultations (weekly during treatment, fortnightly for six weeks and then ‘as needed’). You will not be aware of whether you are participating in the 'control' or 'intervention' phase.

EAT is a dietitian delivered health behaviour change intervention designed to improve health behaviours of head and neck cancer patients and maintain their nutrition over the course of their radiotherapy. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube.

Participants will be regularly assessed for up to 12 weeks post radiotherapy treatment in order to evaluate nutrition status. Information about mood, smoking and alcohol use, therapeutic alliance and radiotherapy side effects will also be collected from participants. Medical records will be reviewed to collect a range of information including total radiotherapy treatment time, unplanned hospital visits, length of stay, dietitian contact and referral to appropriate services for depression.
Trial website
Trial related presentations / publications
Conferences:
Britton, B., Baker, A., Bauer, J., Wolfenden, L., Wratten, C., Beck, A., McElduff, P. & Carter, G., EAT: A stepped wedge cluster randomised trial to improve nutrition in head and neck cancer patients undergoing radiotherapy 14th World Congress of Psycho-Oncology and Psychosocial Academy, Brisbane, Nov 2012, [Poster]

Beck, A.K., Baker, A.L., Britton, B. B., Carter, G., Bauer, J., Wratten, C., Wolfenden, L., McElduff, P. & Thornton, L. Therapeutic Alliance between Dietitians and Patients with Head and Neck Cancer Relationship to Quality of Life and Nutritional Status following a Dietitian Delivered Health Behavior Intervention, COSA's 39th Annual Scientific Meeting, Brisbane, Nov 2012 [Poster]

Baker, A.L., Beck, A.K., Britton, B. B., Carter, G., Bauer, J., Wratten, C., Wolfenden, L., McElduff, P. & Thornton, L. Alcohol, Tobacco Use and Readiness to Change in an Australian Sample of Head and Neck Cancer Patients Undergoing Radiotherapy, COSA's 39th Annual Scientific Meeting, Brisbane, Nov 2012 [Poster]
Public notes

Contacts
Principal investigator
Name 38458 0
Prof Amanda Baker
Address 38458 0
Priority Research Centre for Translational Neuroscience and Mental Health,
University of Newcastle,
PO Box 833,
Newcastle, NSW 2300
Country 38458 0
Australia
Phone 38458 0
+61 2 40335690
Fax 38458 0
+61 2 4033 5692
Email 38458 0
Amanda.Baker@newcastle.edu.au
Contact person for public queries
Name 38459 0
Dr Alison Beck
Address 38459 0
Trial Coordinator,
Priority Research Centre for Translational Neuroscience and Mental Health,
University of Newcastle,
PO Box 833,
Newcastle, NSW 2300
Country 38459 0
Australia
Phone 38459 0
+61 2 4033 5039
Fax 38459 0
+61 2 4033 5692
Email 38459 0
Alison.Beck@newcastle.edu.au
Contact person for scientific queries
Name 38460 0
Prof Amanda Baker
Address 38460 0
Chief Investigator,
Priority Research Centre for Translational Neuroscience and Mental Health,
University of Newcastle,
PO Box 833,
Newcastle, NSW 2300
Country 38460 0
Australia
Phone 38460 0
+61 2 40335690
Fax 38460 0
+61 2 4033 5692
Email 38460 0
Amanda.Baker@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results