Trial Review

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
ACTRN12606000055505
Ethics application status
Approved
Date submitted
23/12/2003
Date registered
23/12/2003
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cancer Pain Education for Patients
Scientific title
Cancer Pain Education for patients to improve pain, knowledge and attitudes and quality of life in patients with advanced cancer
Secondary ID [1] 238 0
National Clinical Trials Registry: NCTR492
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 1019 0
Condition category
Condition code
Cancer 1095 1095 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education package consisting of booklet and video. Patients are randomised to receive booklet or video or both or standard care. The video is watched at the beginning of the four week trial period. Those randomised to standard care have the opportunity of reviewing the materials on completion of the outcome measure questionnaires at 4 weeks.
Intervention code [1] 854 0
None
Comparator / control treatment
Standard Care
Control group
Active

Outcomes
Primary outcome [1] 1461 0
Pain knowledge
Timepoint [1] 1461 0
Barriers questionnaire at 2 and 4 weeks
Primary outcome [2] 1462 0
Attitudes
Timepoint [2] 1462 0
Barriers questionnaire at 2 and 4 weeks
Secondary outcome [1] 2619 0
Pain NRS
Timepoint [1] 2619 0
At 2 and 4 weeks.
Secondary outcome [2] 2620 0
Brief Pain Inventory
Timepoint [2] 2620 0
At 2 and 4 weeks.
Secondary outcome [3] 2621 0
HADS
Timepoint [3] 2621 0
At 2 and 4 weeks.
Secondary outcome [4] 2622 0
Uniscale global quality of life
Timepoint [4] 2622 0
At 2 and 4 weeks.

Eligibility
Key inclusion criteria
Pain >/= 2/10 on a numeric rating scale in the last week, outpatient, prognosis> 1month, advanced cancer, English speaking, cognitive functioning to complete baseline questionnaires.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hearing or vision impaired.

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)
central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers (from Table D1 from Table XXXIII of Fisher and Yates: Statistical Tables for Biological, agricultural and Medical Research, published by Longman Group Ltd London.) Each centre allocated blocks of numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1197 0
Charities/Societies/Foundations
Name [1] 1197 0
Friends of the Mater
Country [1] 1197 0
Australia
Funding source category [2] 1198 0
Charities/Societies/Foundations
Name [2] 1198 0
Cancer Trials New South Wales
Country [2] 1198 0
Australia
Primary sponsor type
Individual
Name
Melanie Lovell
Address
Country
Secondary sponsor category [1] 1058 0
None
Name [1] 1058 0
Nil
Address [1] 1058 0
Country [1] 1058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2520 0
St Vincents
Ethics committee address [1] 2520 0
Ethics committee country [1] 2520 0
Australia
Date submitted for ethics approval [1] 2520 0
Approval date [1] 2520 0
Ethics approval number [1] 2520 0
Ethics committee name [2] 2521 0
Mater
Ethics committee address [2] 2521 0
Ethics committee country [2] 2521 0
Australia
Date submitted for ethics approval [2] 2521 0
Approval date [2] 2521 0
Ethics approval number [2] 2521 0
Ethics committee name [3] 2522 0
Royal Prince Alfred
Ethics committee address [3] 2522 0
Ethics committee country [3] 2522 0
Australia
Date submitted for ethics approval [3] 2522 0
Approval date [3] 2522 0
Ethics approval number [3] 2522 0
Ethics committee name [4] 2523 0
Royal North Shore
Ethics committee address [4] 2523 0
Ethics committee country [4] 2523 0
Australia
Date submitted for ethics approval [4] 2523 0
Approval date [4] 2523 0
Ethics approval number [4] 2523 0
Ethics committee name [5] 2524 0
Concord
Ethics committee address [5] 2524 0
Ethics committee country [5] 2524 0
Australia
Date submitted for ethics approval [5] 2524 0
Approval date [5] 2524 0
Ethics approval number [5] 2524 0
Ethics committee name [6] 2525 0
Prince of Wales
Ethics committee address [6] 2525 0
Ethics committee country [6] 2525 0
Australia
Date submitted for ethics approval [6] 2525 0
Approval date [6] 2525 0
Ethics approval number [6] 2525 0
Ethics committee name [7] 2526 0
St George
Ethics committee address [7] 2526 0
Ethics committee country [7] 2526 0
Australia
Date submitted for ethics approval [7] 2526 0
Approval date [7] 2526 0
Ethics approval number [7] 2526 0
Ethics committee name [8] 2527 0
Greenwich
Ethics committee address [8] 2527 0
Ethics committee country [8] 2527 0
Australia
Date submitted for ethics approval [8] 2527 0
Approval date [8] 2527 0
Ethics approval number [8] 2527 0
Ethics committee name [9] 2528 0
Nepean
Ethics committee address [9] 2528 0
Ethics committee country [9] 2528 0
Australia
Date submitted for ethics approval [9] 2528 0
Approval date [9] 2528 0
Ethics approval number [9] 2528 0
Ethics committee name [10] 2529 0
Orange
Ethics committee address [10] 2529 0
Ethics committee country [10] 2529 0
Australia
Date submitted for ethics approval [10] 2529 0
Approval date [10] 2529 0
Ethics approval number [10] 2529 0
Ethics committee name [11] 2530 0
Parkes
Ethics committee address [11] 2530 0
Ethics committee country [11] 2530 0
Australia
Date submitted for ethics approval [11] 2530 0
Approval date [11] 2530 0
Ethics approval number [11] 2530 0
Ethics committee name [12] 2531 0
Bathurst
Ethics committee address [12] 2531 0
Ethics committee country [12] 2531 0
Australia
Date submitted for ethics approval [12] 2531 0
Approval date [12] 2531 0
Ethics approval number [12] 2531 0
Ethics committee name [13] 2532 0
Lismore Base
Ethics committee address [13] 2532 0
Ethics committee country [13] 2532 0
Australia
Date submitted for ethics approval [13] 2532 0
Approval date [13] 2532 0
Ethics approval number [13] 2532 0
Ethics committee name [14] 2533 0
St Vincents Lismore
Ethics committee address [14] 2533 0
Ethics committee country [14] 2533 0
Australia
Date submitted for ethics approval [14] 2533 0
Approval date [14] 2533 0
Ethics approval number [14] 2533 0
Ethics committee name [15] 2534 0
Tweed River
Ethics committee address [15] 2534 0
Ethics committee country [15] 2534 0
Australia
Date submitted for ethics approval [15] 2534 0
Approval date [15] 2534 0
Ethics approval number [15] 2534 0
Ethics committee name [16] 2535 0
Dubbo
Ethics committee address [16] 2535 0
Ethics committee country [16] 2535 0
Australia
Date submitted for ethics approval [16] 2535 0
Approval date [16] 2535 0
Ethics approval number [16] 2535 0
Ethics committee name [17] 2536 0
Tamworth
Ethics committee address [17] 2536 0
Ethics committee country [17] 2536 0
Australia
Date submitted for ethics approval [17] 2536 0
Approval date [17] 2536 0
Ethics approval number [17] 2536 0
Ethics committee name [18] 2537 0
Braeside
Ethics committee address [18] 2537 0
Ethics committee country [18] 2537 0
Australia
Date submitted for ethics approval [18] 2537 0
Approval date [18] 2537 0
Ethics approval number [18] 2537 0
Ethics committee name [19] 2538 0
Liverpool
Ethics committee address [19] 2538 0
Ethics committee country [19] 2538 0
Australia
Date submitted for ethics approval [19] 2538 0
Approval date [19] 2538 0
Ethics approval number [19] 2538 0

Summary
Brief summary
This is a trial addressing the significant problem of cancer pain and the role of educational materials to improve patients' knowledge about pain relief and thereby improve pain and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35145 0
Address 35145 0
Country 35145 0
Phone 35145 0
Fax 35145 0
Email 35145 0
Contact person for public queries
Name 10043 0
Ruth Toppler
Address 10043 0
Clinical Trials Coordinator and Data Manager
Patricia Ritchie Centre for Cancer Care and Research
Mater Hospital
PO Box 958
North Sydney NSW 2059
Country 10043 0
Australia
Phone 10043 0
+61 2 99547462
Fax 10043 0
+61 2 99540536
Email 10043 0
[email protected]
Contact person for scientific queries
Name 971 0
Dr Melanie Lovell
Address 971 0
Sacred Heart
170 Darlinghurst Road
Darlinghurst NSW 2010
Country 971 0
Australia
Phone 971 0
+61 2 83829444
Fax 971 0
+61 2 83829518
Email 971 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.