Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000871943
Ethics application status
Approved
Date submitted
5/08/2011
Date registered
16/08/2011
Date last updated
16/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of nutrition counselling on nutritional status and quality of life in patients with colorectal cancer undergoing chemotherapy
Scientific title
Improving nutritional status and quality of life in patients with colorectal cancer undergoing chemotherapy: an intensive individualised nutrition counselling and lifestyle programme versus usual standard care
Secondary ID [1] 262789 0
Nil
Universal Trial Number (UTN)
U1111-1120-5586
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 270496 0
Condition category
Condition code
Cancer 270655 270655 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 : Intervention group - These patients will receive an intensive individualised diet and lifestyle intervention for 8 weeks. There will be counselling by a reseacher (dietitian) using a standard protocol: the American Dietetic Association Medical Nutrition Therapy (ADA MNT) protocol for cancer patients (ADA 1998). Each visit will take between 20 and 30 minutes one on one with the dietitian for dietary counselling. These patients will receive dietary counselling at baseline, week 4 and week 8 only. The main goal of an intensive counselling intervention is to enable every patient to achieve his or her calculated energy and protein requirements. This will involve the prescription of a therapeutic diet which will be further modified to provide for individual requirements. Advice on managing symptoms that negatively impact on eating and nutritional status will be also provided. Individually tailored sample meal plans and recipe suggestions will also be provided as and when required during the face-to-face sessions. General advice on physical activity will also be provided. Dietetic counselling will be conducted at baseline, week 4 and week 8 then followed up by motivational sessions that will be reinforced at regular intervals through phone calls once a week during the 8 week intervention.

Arm 2: Control group - These patients will receive the standard practice of the clinic (ie, a general nutrition talk by the dietitian and information on nutrition and cancer in form of a booklet). The booklet used in this study is in English and Malay language . Those who are assessed as having moderate and severe malnutrition will be referred to see a dietitian for nutrition counselling. However, the intervention group will receive tailored and more intensive and ongoing nutrition support and lifestyle advice as compared with the control group.
Intervention code [1] 269134 0
Treatment: Other
Intervention code [2] 269135 0
Lifestyle
Intervention code [3] 269136 0
Behaviour
Comparator / control treatment
Standard practice/treatment
Control group
Active

Outcomes
Primary outcome [1] 269375 0
Primary outcome: nutritional status as determined by PG-SGA score.
Timepoint [1] 269375 0
At baseline and at 4, 8, 20 weeks after intervention commencement.
Secondary outcome [1] 287504 0
Secondary Outcome 1: quality of life as assessed using the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core30 (EORTC-QLQ-C30) and the newly validated colorectal cancer specific module (EORTC QLQ-CR29)
Timepoint [1] 287504 0
At baseline and at 4, 8, 20 weeks after intervention commencement.
Secondary outcome [2] 287505 0
Secondary Outcome 2: changes of body weight and body fat as assessed using Body Mass Index (BMI) calculation, waist circumference and the Omron body fat percentage
Timepoint [2] 287505 0
At baseline and at 4, 8, 20 weeks after intervention commencement.
Secondary outcome [3] 287506 0
Secondary Outcome 3: dietary changes as assessed using the diet history and multiple 24 hour diet recalls
Timepoint [3] 287506 0
At baseline and at 4, 8, 20 weeks after intervention commencement.
Secondary outcome [4] 287507 0
Secondary Outcome 4: serum albumin, prealbumin, transferrin, C-reactive protein, Interleukin 6 as assessed using laboratory assessment and medical record
Timepoint [4] 287507 0
At baseline and at 4, 8, 20 weeks after intervention commencement.
Secondary outcome [5] 287508 0
Secondary Outcome 5: pattern of physical activities as assessed using The Godin Leisure-Time Exercise Questionnaire
Timepoint [5] 287508 0
At baseline and at 4, 8, 20 weeks after intervention commencement.
Secondary outcome [6] 287509 0
Secondary Outcome 6: cognitive behavioural changes as assessed using a adopted questionnaire of the cognitive and behavioural theory
Timepoint [6] 287509 0
At baseline and at 4, 8, 20 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Patients with colorectal cancer who have completed surgery
Aged equal to 18 years old and above
Provides written informed consent
Willing to comply to study procedures
Able to read and write in Malay language
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Had a diagnosis of other cancer.
Involved in another research project.

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)
All patients with colorectal cancer going for his/her first chemotherapy will recruited via referral by the oncologist in the oncologist clinic at Hospital Kuala Lumpur and Hospital Selayang Malaysia based on the inclusion criteria. Their participation is voluntary with informed consent. They will be block randomised into an intervention or a control group. Allocation is not concealed in this study.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3771 0
Malaysia
State/province [1] 3771 0

Funding & Sponsors
Funding source category [1] 269608 0
University
Name [1] 269608 0
Fundamental Research Grants Scheme (FRGS)
Country [1] 269608 0
Malaysia
Primary sponsor type
University
Name
Professor Lynne Cobiac
Address
Nutrition and Dietetics,
Flinders University,
SA 5042
Country
Australia
Secondary sponsor category [1] 266643 0
None
Name [1] 266643 0
Address [1] 266643 0
Country [1] 266643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269558 0
Southern Adelaide Health Service/Flinders University Human Research Ethics Committee
Ethics committee address [1] 269558 0
Ethics committee country [1] 269558 0
Australia
Date submitted for ethics approval [1] 269558 0
Approval date [1] 269558 0
01/03/2011
Ethics approval number [1] 269558 0
1/10/0465
Ethics committee name [2] 269559 0
The Ministry of Health Medical Research Ethics Committee (MREC) Malaysia
Ethics committee address [2] 269559 0
Ethics committee country [2] 269559 0
Malaysia
Date submitted for ethics approval [2] 269559 0
Approval date [2] 269559 0
21/07/2011
Ethics approval number [2] 269559 0
NMRR-11-285-8064

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32984 0
Address 32984 0
Country 32984 0
Phone 32984 0
Fax 32984 0
Email 32984 0
Contact person for public queries
Name 16231 0
Zalina Abu Zaid
Address 16231 0
Nutrition and Dietetic Department
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 16231 0
Australia
Phone 16231 0
+61 8 82045186
Fax 16231 0
+61 8 82046406
Email 16231 0
[email protected]
Contact person for scientific queries
Name 7159 0
Professor Lynne Cobiac
Address 7159 0
CSIRO Food and Nutritional Sciences
Gate 13, Kintore Avenue,
Adelaide
SA 5000
Country 7159 0
Australia
Phone 7159 0
+61 8 83050607
Fax 7159 0
+61 8 83038837
Email 7159 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.