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Trial registered on ANZCTR


Registration number
ACTRN12606000178549
Ethics application status
Approved
Date submitted
15/05/2006
Date registered
16/05/2006
Date last updated
16/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Meeting the information needs and improving the quality of life of patients beginning chemotherapy treatment.
Scientific title
Meeting the information needs and improving the quality of life of cancer patients beginning chemotherapy treatment through an educational intervention to improve pre-treatment anxiety.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer patients receiving their first course of chemotherapy ever 1151 0
Condition category
Condition code
Cancer 1231 1231 0 0
Mental Health 1232 1232 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a tailored intervention drawing on the best evidence in four key domains: 1) preparing patients for potentially threatening procedures, 2) tailoring to the specific needs of the individual, 3) emphasising self-care, 4) psychosocial support. The intervention group will receive chemotherapy education from an experienced nurse prior to their first chemotherapy which may last up to one hour. The second intervention is a telephone call 24-48 hours post chemotherapy and then the third (and last) intervention is prior to the 2nd cycle of chemotherapy to encourage self-care measures. This last session may take up to fifteen minutes and is scheduled dependent on the chemotherapy regime the patient is receiving(it could be two, three or four weeks post the first cycle of treatment).
Intervention code [1] 1041 0
Other interventions
Comparator / control treatment
The control group will receive usual care.
Control group
Active

Outcomes
Primary outcome [1] 1670 0
For the patients in the intervention group to demonstrate a significant reduction in anxiety and depression prior to the commencement of cycle 3 of their chemotherapy.
Timepoint [1] 1670 0
The final questionnaire is given to the patient on the day of their third cycle of chemotherapy. The cycles of chemotherapy are dependent on the treatment regimen, they could be every two weeks, every three weeks or every four weeks.
Secondary outcome [1] 2990 0
Other outcomes include reduction in self-reported distress associated with common effects of chemotherapy, reduction in perceived needs and improvement in perceived confidence in coping with cancer treatment and side effects.
Timepoint [1] 2990 0
Questionnaires are delivered to all patients prior to randomisation, at the commencement of chemotherapy and at the beginning of the 3rd cycle of treatment. The final questionnaire is given to the patient on the day of their third cycle of chemotherapy. The cycles of chemotherapy are dependent on the treatment regimen, they could be every two weeks, every three weeks or every four weeks.

Eligibility
Key inclusion criteria
1. Diagnosis of cancer2. receiving their first course of IV chemotherapy ever, with at least 3 cycles of treatment being planned. 3. Able to participate in the data collection process.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Currently undergoing psychiatric treatment2. ECOG >2

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 was concealed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Adaptive biased coin
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two group randomised controlled trial
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1346 0
Charities/Societies/Foundations
Name [1] 1346 0
The leukaemia Foundation of Victoria
Country [1] 1346 0
Australia
Funding source category [2] 1347 0
Government body
Name [2] 1347 0
NHMRC
Country [2] 1347 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter Maccallum cancer centre
Address
Country
Australia
Secondary sponsor category [1] 1191 0
None
Name [1] 1191 0
Nil
Address [1] 1191 0
Country [1] 1191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2699 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2699 0
Ethics committee country [1] 2699 0
Australia
Date submitted for ethics approval [1] 2699 0
Approval date [1] 2699 0
25/08/2004
Ethics approval number [1] 2699 0
04/44

Summary
Brief summary
The purpose of this project is to test a new way of providing patients with information about chemotherapy. Previous experience has shown that many patients feel anxious before starting chemotherapy treatment, and would like the opportunity to discuss their concerns about treatment, treatment related side effects and ask questions. Patients will be randomly allocated to receive either the usual chemotherapy education program or the new chemotherapy education program we are testing. The two groups will be compared on measures of psychological distress, symptoms/side effects of chemotherapy, confidence in dealing with side effects of chemotherapy and unmet needs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35153 0
Address 35153 0
Country 35153 0
Phone 35153 0
Fax 35153 0
Email 35153 0
Contact person for public queries
Name 10230 0
Ms Melanie Evans
Address 10230 0
Locked Bag #1
A'Beckett St
Melbourne VIC 8006
Country 10230 0
Australia
Phone 10230 0
+61 3 96561799
Fax 10230 0
Email 10230 0
[email protected]
Contact person for scientific queries
Name 1158 0
Prof Sanchia Aranda
Address 1158 0
Locked Bag #1
A'Beckett St
Melbourne VIC 8006
Country 1158 0
Australia
Phone 1158 0
+61 3 96563783
Fax 1158 0
Email 1158 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.