Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.