Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001009707
Ethics application status
Approved
Date submitted
10/09/2013
Date registered
11/09/2013
Date last updated
18/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
ANZ 1302A - Study to investigate the importance of aromatase inhibitor-induced musculoskeletal syndrome (AIMSS) in Australian women with breast cancer on aromatase inhibitors
Scientific title
ANZ 1302A - An online survey to evaluate the incidence and clinical impact of aromatase inhibitor-induced musculoskeletal syndrome (AIMSS) in Australian women with a diagnosis of breast cancer since 2007 being treated with an adjuvant aromatase inhibitor currently or since their diagnosis
Secondary ID [1] 283182 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aromatase Inhibitor-Induced Musculoskeletal Syndrome (AIMSS) 290040 0
Breast Cancer 290053 0
Condition category
Condition code
Cancer 290417 290417 0 0
Breast
Musculoskeletal 290429 290429 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Online survey.

Each participant will do the survey once. The questionnaire will take approximately 15 minutes.

The first few questions are to check that the interview is right for the participant.

The rest of the questions will ask about:
* The participant's experience with aromatase inhibitors
* Management of side effects of aromatase inhibitors with prescription medication
* Management of side effects of aromatase inhibitors with over the counter medications
* Management of side effects of aromatase inhibitors with alternative/complementary therapies
* Chemotherapy treatment for their cancer
* Vitamin D testing
Intervention code [1] 287907 0
Not applicable
Comparator / control treatment
No comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290442 0
The percentage of respondents who report AIMSS and reported manifestations of AIMSS
Timepoint [1] 290442 0
At completion of all participant online surveys
Primary outcome [2] 290443 0
The percentage of respondents who report discontinuation of an aromatase inhibitor due to AIMSS and identification of factors associated with the discontinuation of aromatase inhibitors
Timepoint [2] 290443 0
At completion of all participant online surveys
Primary outcome [3] 290444 0
The percentage of respondents who switched endocrine treatment and the effectiveness of that strategy on their AIMSS according to participant responses to specific questions in the online survey
Timepoint [3] 290444 0
At completion of all participant online surveys
Secondary outcome [1] 304525 0
Number and type of medications used for AIMSS and effectiveness of those medications according to participant responses to specific questions in the online survey
Timepoint [1] 304525 0
At completion of all participant online surveys
Secondary outcome [2] 304526 0
Number and type of alternative therapies used for AIMSS and their effectiveness according to participant responses to specific questions in the online survey
Timepoint [2] 304526 0
At completion of all participant online surveys

Eligibility
Key inclusion criteria

1) Must be female, >=18 years
2) Must have a diagnosis of Early Breast Cancer (stage 1-3) in 2007 or later
3) Must be taking adjuvant AI in any setting (up-front, switch, extended) currently or at any time since their breast cancer diagnosis
4) Must be able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Insufficient English language skills for participation
2) Diagnosis of DCIS only or with metastatic breast cancer

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
This study is descriptive in nature. Outcomes will include:
* The percentage of respondents who report AIMSS
* Reported manifestations of AIMSS
* The percentage of respondents who report discontinuation of an aromatase inhibitor due to AIMSS
* Identified factors associated with discontinuation of AIs
* The percentage of respondents who switched endocrine treatment, and the effectiveness of that strategy on their AIMSS
* Number and type of medications used for AIMSS and effectiveness of those medications
* Number and type of alternative therapies used for AIMSS and their effectiveness

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
18/03/2014
Date of last participant enrolment
Anticipated
30/05/2014
Actual
30/05/2014
Date of last data collection
Anticipated
30/05/2014
Actual
30/05/2014
Sample size
Target
500
Accrual to date
Final
594
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287929 0
Other Collaborative groups
Name [1] 287929 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 287929 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group
Address
PO Box 155
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 286655 0
None
Name [1] 286655 0
Address [1] 286655 0
Country [1] 286655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289860 0
Hunter New England HREC
Ethics committee address [1] 289860 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 289860 0
Australia
Date submitted for ethics approval [1] 289860 0
17/12/2013
Approval date [1] 289860 0
19/12/2013
Ethics approval number [1] 289860 0

Summary
Brief summary
This study aims to use an online survey to gather information on the incidence and clinical impact of Aromatase Inhibitor-Induced Musculoskeletal Syndrome (AIMSS) in Australian women.

Who is it for?
You may be eligible to join this study if you are 18 years or older, female, have had a diagnosis of early breast cancer since 2007 and have been taking an aromatase inhibitor at any time since your diagnosis.

Trial details.
Many women with breast cancer are prescribed aromatase inhibitors as part of their breast cancer treatment. It is known that some women experience side effects from aromatase inhibitors which disrupt their quality of life. Some women may even choose to stop taking their medication before they have completed the recommended course (usually five years).

This survey will ask a number of questions about women's experiences with side effects from aromatase inhibitors. The survey focuses specifically on joint, muscle and tendon pain, stiffness and discomfort. Women who have not had joint or muscle symptoms are also welcome to take part.

The survey will assist the researchers to:
* Better understand how the side effects of aromatase inhibitors affect Australian women.
* Investigate possible ways of reducing these symptoms
* Look at ways of improving the way doctors and other health professionals measure women’s symptoms and their impact on quality of life.
Trial website
Trial related presentations / publications
Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Supportive Care in Cancer 2015; epub 10 November 2015:1-8.
Public notes

Contacts
Principal investigator
Name 42802 0
A/Prof Jacquie Chirgwin
Address 42802 0
Box Hill and Maroondah Hospitals
Maroondah Breast Clinic
20 Grey Street
Ringwood East VIC 3135
Country 42802 0
Australia
Phone 42802 0
+61 3 9871 3582
Fax 42802 0
Email 42802 0
[email protected]
Contact person for public queries
Name 42803 0
Jacquie Chirgwin
Address 42803 0
Box Hill and Maroondah Hospitals
Maroondah Breast Clinic
20 Grey Street
Ringwood East VIC 3135
Country 42803 0
Australia
Phone 42803 0
+61 3 9871 3582
Fax 42803 0
Email 42803 0
[email protected]
Contact person for scientific queries
Name 42804 0
Jacquie Chirgwin
Address 42804 0
Box Hill and Maroondah Hospitals
Maroondah Breast Clinic
20 Grey Street
Ringwood East VIC 3135
Country 42804 0
Australia
Phone 42804 0
+61 3 9871 3582
Fax 42804 0
Email 42804 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.