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Trial registered on ANZCTR


Registration number
ACTRN12611000005954
Ethics application status
Approved
Date submitted
15/11/2010
Date registered
4/01/2011
Date last updated
4/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring potential benefit of earlier nutritional interventions in adults with upper gastrointestinal cancer: a randomised trial
Scientific title
Pilot study of efficacy of an early and intensive nutrition intervention model, compared to usual care, for improving health-related quality of life amongst patients with oesophageal or stomach cancer
Secondary ID [1] 253093 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 258655 0
Stomach cancer 258656 0
Condition category
Condition code
Cancer 258794 258794 0 0
Oesophageal (gullet)
Cancer 258795 258795 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will undergo an initial nutritional assessment via telephone within 2 days of receipt of referral from the treating consultant. Participants will receive individualised nutrition care in the form of weekly intensive nutrition assessment and nutrition intervention by the research dietitian via telephone contact interview or face to face interview if attending Monash Medical Centre and written nutritional education information regarding nutrition impact symptoms and dietary management. Dietitian interviewers will try to ascertain information in the areas of; i) oral intake/food intake, ii) presence/absence of nutrition impact symptoms, iii) physical function, and iv) other relevant dietary information. The initial telephone call will last approximately 30 minutes as a detailed dietetic interview will be conducted. Follow-up telephone calls are anticipated to last approximately 15 minutes. Motivational interviewing techniques will be incorporated into the follow-up telephone calls to promote adherence to the recommended course of action. Oral nutritional supplement samples will be provided as required at the discretion of the treating dietitian. Patients will be consulted weekly for 18 weeks and then at week 26.
Intervention code [1] 257613 0
Prevention
Intervention code [2] 257667 0
Lifestyle
Comparator / control treatment
Participants in the control group will receive usual nutrition care services. Usual nutrition care involves no dietetic input until the patient is admitted for surgery or chemotherapy. A dietitian sees the patient at the point of surgery or commencement of chemotherapy. A malnutrition screen (Malnutrition Screening Tool) is then completed at chemotherapy and patients scoring above the threshold of 2 are then referred for hospital based dietitian services. These are individualized services of length and frequency at the discretion of the treating dietitian in response to their perception of patient need.
Control group
Active

Outcomes
Primary outcome [1] 259664 0
EQ-5D (European Quality of Life index) with visual analogue scale
Timepoint [1] 259664 0
Baseline (study entry) taken at initial diagnosis.
At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)
At the time of surgery (if suregery is provided)
26 week post-initial assessment
Secondary outcome [1] 266350 0
European Organisation for Research and Treatment in Cancer - C30 instrument
Timepoint [1] 266350 0
Baseline (study entry) taken at initial diagnosis.
At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)
At the time of surgery (if suregery is provided)
26 week post-initial assessment
Secondary outcome [2] 266351 0
Participant self-reported weight in kilograms
Timepoint [2] 266351 0
Baseline (study entry) taken at initial diagnosis.
At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)
At the time of surgery (if suregery is provided)
26 week post-initial assessment
Secondary outcome [3] 266352 0
Patient Generated Subjective Global Assessment
Timepoint [3] 266352 0
Baseline (study entry) taken at initial diagnosis.
At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)
At the time of surgery (if suregery is provided)
26 week post-initial assessment

Eligibility
Key inclusion criteria
Inclusion:
i) All patients with a histological proven diagnosis of cancer of the oesophagus or stomach who are to undergo surgery and/or chemotherapy at Southern Health
ii) Provision of consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
i) Under 18 years of age
ii) Patients diagnosed with recurrent disease
iii) Patients with physical, cognitive, language or emotional problems would prevent participation as determined by treating consultant
iv) Patients who were to undergo surgery and/or chemotherapy at another health service

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients under the care of Southern Health, Upper Gastro-intestinal Cancer consultants with a new diagnosis of histological proven oesophageal or stomach cancer who met the inclusion criteria will be referred to the Department of Dietetics, Monash Medical Centre, Clayton. Patients will be provided with a brief verbal description and information sheet of the project by their treating consultant. Consultants will ask whether the participant is happy to be contacted by the research dietitian to have the project explained in further detail. A referral will be sent to the research dietitian by the consultant.
Agreeable participants will then be contacted by a research dietitian and will be provided with a full verbal description of the project via telephone. Potential participants who agree to participate will be asked to provide verbal consent to participate in the trial via the telephone. Verbal consent will be recorded.

Consenting participants will receive in the mail a letter explaining the research, a withdrawal to consent form and written copies of survey-based outcome measures. If a participant decides to withdraw from the trial they will be asked to complete the withdrawal to consent form and return to a research dietitian. A research assistant will collect the information via telephone 2 days later.
Participants will then be randomised into the intervention or control group. The method of randomization will be through use of opaque, consecutively numbered, sealed envelopes with the group allocation written on a piece of paper inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be constructed using a computer random number generator. Randomisation will be stratified by diagnosis (oesophageal or stomach cancer). Permuted blocks will also be used to help ensure relatively even numbers of participants between groups within strata.
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

Recruitment
Recruitment status
Not yet 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
Recruitment postcode(s) [1] 3441 0
3175
Recruitment postcode(s) [2] 3529 0
3168

Funding & Sponsors
Funding source category [1] 258062 0
Hospital
Name [1] 258062 0
Southern Health
Address [1] 258062 0
Monash Medical Centre
Department of Dietetics
246 Clayton Rd
Clayton 3168
Vic
Country [1] 258062 0
Australia
Primary sponsor type
Individual
Name
Mary Anne Silvers
Address
Department of Dietetics
Monash Medical Centre
246 Clayton Rd
Clayton 3168
Vic
Country
Australia
Secondary sponsor category [1] 257253 0
Individual
Name [1] 257253 0
Assoc Prof Terry Haines
Address [1] 257253 0
Kingston Centre
Kingston Rd
Cheltenham
Vic
3192
Country [1] 257253 0
Australia
Secondary sponsor category [2] 257254 0
Individual
Name [2] 257254 0
Professor Helen Truby
Address [2] 257254 0
Department of Nutrition and Dietetics
Monash University
Block E, Level 5
Monash Medical Centre
246 Clayton Rd
Clayton Vic 3168
Country [2] 257254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260237 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 260237 0
Research Directorate
Monash Medical Centre
Clayton Rd
Clayton
3168
Victoria
Australia
Ethics committee country [1] 260237 0
Australia
Date submitted for ethics approval [1] 260237 0
Approval date [1] 260237 0
12/11/2010
Ethics approval number [1] 260237 0
10267B

Summary
Brief summary
This study looks at the efficacy of an early and frequent nutrition intervention model, compared to usual care, for improving the quality of life in people with oesophageal or stomach cancer

Who is it for?
You can join this study if you have cancer of the oesophagus or stomach and will have surgery and/or chemotherapy at Southern Health in Victoria.

Trial details
Participants will be i n two groups. One group will receive the usual dietetic consultation at the time of surgery or chemotherapy which involves a completing a malnutrition screening questionnaire and referral to hospital dietician services if appropriate. The other group will receive early (at the time of diagnosis) and frequent dietetic assessment. This will involve an initial telephone or face-to-face interview lasting at least 30 minutes and weekly follow-up telephone calls lasting 15 minutes for 18 weeks and then at week 26. Oral nutritional supplement samples will be given to participants at the discretion of the treating dietician.

The aim of the study is to compare the quality of life, nutritional status and patient satisfaction with dietetic intervention in the two groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31917 0
Address 31917 0
Country 31917 0
Phone 31917 0
Fax 31917 0
Email 31917 0
Contact person for public queries
Name 15164 0
Mary Anne Silvers
Address 15164 0
Department of Dietetics
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria 3168
Country 15164 0
Australia
Phone 15164 0
+61 3 9594 4182
Fax 15164 0
Email 15164 0
maryanne.silvers@southernhealth.org.au
Contact person for scientific queries
Name 6092 0
Professor Terry Haines
Address 6092 0
Allied Health Clinical Research Unit
Kingston Centre
Cnr Warrigal Rd and Kingston Rds
Cheltenham, Victoria, Australia 3192
Country 6092 0
Australia
Phone 6092 0
+61 3 9265 1774
Fax 6092 0
Email 6092 0
Terrence.haines@southernhealth.org.au

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