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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
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
Other design features
Two group randomised controlled trial
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1346 0
Name [1] 1346 0
The leukaemia Foundation of Victoria
Address [1] 1346 0
Country [1] 1346 0
Funding source category [2] 1347 0
Government body
Name [2] 1347 0
Address [2] 1347 0
Country [2] 1347 0
Primary sponsor type
Peter Maccallum cancer centre
Secondary sponsor category [1] 1191 0
Name [1] 1191 0
Address [1] 1191 0
Country [1] 1191 0

Ethics approval
Ethics application status
Ethics committee name [1] 2699 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2699 0
Ethics committee country [1] 2699 0
Date submitted for ethics approval [1] 2699 0
Approval date [1] 2699 0
Ethics approval number [1] 2699 0

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

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
Phone 10230 0
+61 3 96561799
Fax 10230 0
Email 10230 0
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
Phone 1158 0
+61 3 96563783
Fax 1158 0
Email 1158 0

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