Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000171314
Ethics application status
Approved
Date submitted
31/03/2008
Date registered
8/04/2008
Date last updated
7/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial investigating the effects of group education and support in reducing cancer-related fatigue and improving quality of life in patients undergoing radiotherapy.
Scientific title
Do fatigue education and support groups reduce fatigue and improve quality of life in cancer patients undergoing radiotherapy compared with standard treatment?
Universal Trial Number (UTN)
Trial acronym
CAN FIT (Cancer Fatigue Intervention Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue in cancer patients undergoing radiotherapy 2978 0
Condition category
Condition code
Cancer 3123 3123 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre and post radiotherapy education and support groups
Support group last one hour in duration and frequency is dependent on the group the participant is allocated to. ie
Group 1- 2 groups (one before and one after treatment)
Group 2- 1 group before treatment
Group 3- 1 group after treatment
Group 4- No groups
Participants receive education about radiotherapy process, what to expect from treatment, side effects and strategies to use to minimise side effects (including activity modification, education, nutrition, coping strategies, social support, sleep strategies)
Patients will be seen by the radiation oncologist for their initial appointment. The radiation oncologist provides brief education to the patient about the radiotherapy process as is standard care. Radiation Oncologists will be requested to provide a brief introduction to the education sessions.

Eligible patients will be sent an information pack containing the patient information and consent form and a cover letter. Patients will be advised that they can call and decline to participate (by voice mail). If patients do not call within one week of receiving the information pack, they will receive a phone call from the principal investigator to discuss whether they would like to be involved in the project. Further details about the project will be provided as requested and patients will be asked to provide verbal consent over the phone should they wish to participate. Patients who agree to participate will also be asked to sign the consent form in the presence of a witness and return the consent form to the principal investigator in the post-paid envelope provided. Those who consent will be then randomised to a group via simple randomisation and advised of their commitments and first attendance date.
Intervention code [1] 2717 0
Treatment: Other
Comparator / control treatment
Standard treatment - No education and support group
Control group
Active

Outcomes
Primary outcome [1] 4010 0
fatigue using the Multidimensional Fatigue Inventory
Timepoint [1] 4010 0
pre radiotherapy treatment, post radiotherapy treatment, 6 weeks after radiotherapy treatment
Secondary outcome [1] 6748 0
quality of life - using the EQ-5D: European quality of life instrument
Timepoint [1] 6748 0
pre radiotherapy treatment, post radiotherapy treatment, 6 weeks after radiotherapy treatment

Eligibility
Key inclusion criteria
1. Patients >18 years of age receiving radiation therapy at Princess Alexandra Hospital.
2. Patients being treated for a diagnosis of cancer.
3. Patients undergoing treatment with radiation therapy for cure or control of cancer rather than palliation.
4. Karnofsky level 60-100 – The minimum physical capacity for subjects included using this criterion will therefore be that they require only occasional assistance for most personal needs at the baseline assessment.
5. Patients who are able to communicate in English.
6. Patients able to attend group programs outside of radiotherapy times.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients having short course radiation therapy (< 20 fractions) for symptom management only.
2. Patients undergoing chemotherapy during the course of the study.
3. Patients unable to complete questionnaires due to cognitive or literacy limitations.
4. Patients who are involved in programs targeting improvements in fatigue or quality of life
5. Patients who have had previous radiotherapy treatment.

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)
Randomisation envelopes will be kept by a staff member not involved in recruitment and will be obtained individually by the principal investigator after consent is received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 3242 0
Hospital
Name [1] 3242 0
Statewide Cancer Clinical Network
Country [1] 3242 0
Australia
Primary sponsor type
Individual
Name
Amanda Purcell
Address
Occupational Therapy Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba 4102
Country
Australia
Secondary sponsor category [1] 2898 0
None
Name [1] 2898 0
Address [1] 2898 0
Country [1] 2898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5224 0
Princess Alexandra Hospital human Research Ethics Committee
Ethics committee address [1] 5224 0
Ipswich Rd
Woolloongabba 4102
Ethics committee country [1] 5224 0
Australia
Date submitted for ethics approval [1] 5224 0
19/10/2007
Approval date [1] 5224 0
28/11/2007
Ethics approval number [1] 5224 0
2007/183

Summary
Brief summary
This study looks at whether support groups that teach about fatigue can
help reduce fatigue and improve quality of life in cancer patients
undergoing radiotherapy, compared with standard treatment.

Who is it for?

You can join this study if you are a patient at the Princess Alexandra Hospital, receiving radiotherapy for cure or
control of cancer but are not receiving chemotherapy at the same time.

Trial details

Participants will be randomly divided into four groups. Three groups
will attend a patient fatigue education and support (FES) group at
different stages in their treatment, to learn strategies they can use to
improve their levels of fatigue and thus their quality of life. These
three intervention groups will be compared to a control group that
receives only standard care. In standard care, the radiation oncologist and nursing staff provide brief education to the patient about the radiotherapy process,
with no specific patient fatigue education and support group.

Patients will be assessed on a variety of questionnaires to investigate
the effects of the FES groups and will also be asked to keep a log of
the strategies they used to improve their fatigue levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28478 0
Address 28478 0
Country 28478 0
Phone 28478 0
Fax 28478 0
Email 28478 0
Contact person for public queries
Name 11635 0
Amanda Purcell
Address 11635 0
Occupational Therapy Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba 4102
Country 11635 0
Australia
Phone 11635 0
07 3240 5008
Fax 11635 0
07 3240 7207
Email 11635 0
[email protected]
Contact person for scientific queries
Name 2563 0
Amanda Purcell
Address 2563 0
Occupational Therapy Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba 4102
Country 2563 0
Australia
Phone 2563 0
07 3240 5008
Fax 2563 0
07 3240 7207
Email 2563 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.