Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000194965
Ethics application status
Not yet submitted
Date submitted
4/02/2011
Date registered
18/02/2011
Date last updated
18/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an individualised nutrition and exercise support program on quality of life, nutritional status and body composition in cancer patients post-haematopoietic stem cell transplant compared to standard care.
Scientific title
The effect of an individualised nutrition and exercise support program on quality of life, nutritional status and body composition in cancer patients post-haematopoietic stem cell transplant compared to standard care.
Secondary ID [1] 253550 0
NIL
Universal Trial Number (UTN)
U1111-1119-2656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult cancer patients treated with autologous haematopoietic stem cell transplant. 261108 0
Condition category
Condition code
Blood 259254 259254 0 0
Haematological diseases
Cancer 259270 259270 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participants of the intervention group will recieve an individualised nutrition program from the hosptal dietitian and an individualised exercise program from the hospital exercise physiologist:

All transplant patients are regularly reviewed by a dietitian as a part of the hospital care but they are not followed up after discharge. Participant of the intervention group will be followed up by a hospital dietitian fortnightly for a 20-30 minutes dietary counselling to address specific nutirtional need (i.e. food choices).

The exercsie intervention will be variable but in general, patients will undertake a home-based exercise program involving a minimum of 5x30 minutes exercise a week for 12 weeks. Initial consultation (1hour) with the exercise physiologist will be conducted face-to-face in the hospital prior to discharge and subsequent follow up will be done fortnightly (20-30 minutes/session) over the phone after patients are discharged.The type of exercise and the intensity of the activity will be dependent on what is manageable by each patient.
Intervention code [1] 257978 0
Rehabilitation
Intervention code [2] 257995 0
Lifestyle
Comparator / control treatment
Autologous haematopoietic stem cell transplant patients treated with usual care.

Usual care is hospital specific, therefore, the usual care may vary slightly depending on the recruitment site. Transplant patients recieving usual care as defined by this study are transplant patients who are not followed up by a hospital dietitian or exercise physiologist after discharge.
Control group
Active

Outcomes
Primary outcome [1] 262072 0
Quality of life (EORTC QLQ C30)
Timepoint [1] 262072 0
Pre-admission (up to 2 weeks before stem cell transplant), 1 month, and 3 months post-transplant
Secondary outcome [1] 273096 0
Nutritional status as assessed by the patient-generated subjective global assessment (PG-SGA)
Timepoint [1] 273096 0
Pre-admission (up to 2 weeks before stem cell transplant), 1 month, and 3 months post-transplant
Secondary outcome [2] 273097 0
Lean body mass as assessed by air-displacement plethysmography (BODPOD) and tetra-polar bioelectrical impedance analysis (BIA). A sub-sample will be assessed by dual energy X-ray absorptiometry (DEXA).
Timepoint [2] 273097 0
Pre-admission (up to 2 weeks before stem cell transplant), 1 month, and 3 months post-transplant

Eligibility
Key inclusion criteria
Adult cancer patients undergoing autologous haematopoietic stem cell transplant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with disability or any other conditions that contradicts physical activity; patient's with a pace maker; allogeneic haematopoietic stem cell transplant; patients who cannot speak English; and patients with cognitive diseases.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 258433 0
Charities/Societies/Foundations
Name [1] 258433 0
The Wesley Research Institute
Country [1] 258433 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Wesley Research Institute
Address
451 Coronation Drive, Auchenflower, QLD, 4066
Country
Australia
Secondary sponsor category [1] 257581 0
None
Name [1] 257581 0
Address [1] 257581 0
Country [1] 257581 0
Other collaborator category [1] 251799 0
University
Name [1] 251799 0
The University of Queensland
Address [1] 251799 0
The University of Queensland, St. Lucia, Brisbane QLD 4072
Country [1] 251799 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260421 0
Ethics committee address [1] 260421 0
Ethics committee country [1] 260421 0
Date submitted for ethics approval [1] 260421 0
28/02/2011
Approval date [1] 260421 0
Ethics approval number [1] 260421 0

Summary
Brief summary
Patients undergoing haematopietic blood stem cell transplant (HSCT) are primarily treated for haematological cancer. After treatment, these patients can experience a number of side effects affecting their quality of life for up to several years. Common problems observed amongst transplant survivors include weight loss, gastrointestinal symptoms (e.g. nausea, poor appetite, sore mouth and excessive diarrhoea), and fatigue. These symptoms can increase the risks of developing other issues such as poor nutritional status, poorer health status and reduced physical functioning. As a result of the combined factors, some people are unable to return to work or they are unable to perform their usual activities. One of the reasons for physical impairment may be the loss of muscle; and the cause of muscle loss may be the result of reduced physical activity and poor nutritional status. Despite report of these research findings, patients are not routinely followed up by allied health professionals to receive ongoing support.

This study looks at the effects of a combined nutrition advice and individualised exercise program compared to standard care on quality of life, nutritional status and body composition in cancer patients after undergoing haematopoietic stem cell transplant.

Who is it for – Eligible participants are adult cancer patient over the age of 18 and scheduled for autologous haematopoietic stem cell transplant at The Wesley Hospital.
Trial details – Participants will be randomised to one of two groups, either (i) an individualised nutrition program from the hospital dietitian combined with an individualised exercise program from the hospital exercise physiologist, or (ii) usual care as provided as standard by the hospital attended. Participants in the combined group will be followed up by a hospital dietitian fortnightly for a 20-30 minute dietary counselling session to address specific nutritional need (i.e. food choices), and the exercise component will be variable but, in general, patients will undertake a home-based exercise program involving a minimum of 5x30 minutes exercise a week for 12 weeks, and the type and intensity of exercise will be dependent on what is manageable by each patient. There will be a 1 hour consultation with the exercise physiologist conducted face-to-face in the hospital prior to discharge, and subsequent follow up will be done fortnightly (20-30 minutes/session) over the phone after patients are discharged. Participants in the usual care group will receive treatment as usual, according to the recruiting hospital’s standards, and there will be no follow up by a hospital dietitian or exercise physiologist after discharge for this group.

The aim of this study is to determine whether a combined nutrition advice and individualised exercise program may help in the quality of life, nutritional status, and body composition of cancer patients post-haematopoietic stem cell transplant compared to standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32175 0
Address 32175 0
Country 32175 0
Phone 32175 0
Fax 32175 0
Email 32175 0
Contact person for public queries
Name 15422 0
Yui Hung
Address 15422 0
The school of Human Movement Studies, Connell Building, The University of Queensland, St. Lucia, QLD 4067
Country 15422 0
Australia
Phone 15422 0
+61 7 33656313
Fax 15422 0
Email 15422 0
[email protected]
Contact person for scientific queries
Name 6350 0
Yui Hung
Address 6350 0
The school of Human Movement Studies, Connell Building, The University of Queensland, St. Lucia, QLD 4067
Country 6350 0
Australia
Phone 6350 0
+61 7 33656313
Fax 6350 0
Email 6350 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

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Documents added automatically
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