Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000070437
Ethics application status
Approved
Date submitted
19/05/2006
Date registered
22/01/2007
Date last updated
22/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chemo Video Cohort Study
Scientific title
Effect of a chemotherapy information video on cancer patients being treated with chemotherapy with the outcome being an improvement in patient's self-efficacy and reduction in patient's level of anxiety, depression, and supportive care needs.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer patients currently being treated with chemotherapy 1562 0
Condition category
Condition code
Cancer 1661 1661 0 0
Mental Health 1662 1662 0 0
Depression
Mental Health 1663 1663 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 25min video looking at 8 common side effects of chemotherapy, given to the patient at least a 48hrs before starting treatment
Intervention code [1] 1054 0
None
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 2301 0
Psychological distress (anxiety and depression).
Timepoint [1] 2301 0
Measured at one timepoint only, on the day they started chemotherapy
Primary outcome [2] 2302 0
Self efficacy.
Timepoint [2] 2302 0
Measured at one timepoint only, on the day they started chemotherapy
Primary outcome [3] 2303 0
Supportive care needs.
Timepoint [3] 2303 0
Measured at one timepoint only, on the day they started chemotherapy
Secondary outcome [1] 4010 0
Nil
Timepoint [1] 4010 0

Eligibility
Key inclusion criteria
Histologically/ cytologically confirmed cancer diagnosis-Scheduled for first ever treatment of intravenous cytotoxic chemotherapy.- English speaking- males/females/other.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past history of depression or anxiety disorder- Current use of antidepressive or anxiolytic medication- Diagnosis of dementia.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1808 0
Charities/Societies/Foundations
Name [1] 1808 0
Peter MacCallum Cancer Centre
Country [1] 1808 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1628 0
None
Name [1] 1628 0
None
Address [1] 1628 0
Country [1] 1628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3385 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 3385 0
Ethics committee country [1] 3385 0
Australia
Date submitted for ethics approval [1] 3385 0
Approval date [1] 3385 0
26/07/2004
Ethics approval number [1] 3385 0
04/32

Summary
Brief summary
We developed a video to prepare patients for chemotherapy and assist them to self manage side effect. The purpose of this study was to see if patients who watched the video would report: higher confidence in dealing with treatment side effects, lower anxiety, and fewer unmet needs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35618 0
Address 35618 0
Country 35618 0
Phone 35618 0
Fax 35618 0
Email 35618 0
Contact person for public queries
Name 10243 0
Melanie Evans
Address 10243 0
Peter MacCallum Cancer Centre
Education Centre
Level 3
Locked Bag 1 A'Beckett St
Melbourne VIC 8006
Country 10243 0
Australia
Phone 10243 0
+61 3 96561799
Fax 10243 0
+61 3 96561337
Email 10243 0
[email protected]
Contact person for scientific queries
Name 1171 0
Dr Mariko Carey
Address 1171 0
Peter MacCallum Cancer Centre
Education Centre
Level 3
Locked Bag 1 A'Beckett St
Melbourne VIC 8006
Country 1171 0
Australia
Phone 1171 0
+61 3 96561667
Fax 1171 0
+61 3 96561337
Email 1171 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.