Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000383864
Ethics application status
Approved
Date submitted
23/09/2020
Date registered
7/04/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
7/04/2021
Date results information initially provided
22/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysing compliance with Calcium and Vitamin D supplementations in patients receiving bone resorptive agents.
Scientific title
Analysing compliance with Calcium and Vitamin D supplementations in Cancer patients receiving bone resorptive agents.
Secondary ID [1] 302377 0
na
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 319157 0
Multiple Myeloma 319158 0
prostate cancer 319159 0
bone metastasis 319160 0
Breast Cancer 319679 0
Other cancers with bone metastasis 319680 0
Condition category
Condition code
Cancer 317124 317124 0 0
Bone
Cancer 317606 317606 0 0
Breast
Cancer 317607 317607 0 0
Prostate
Cancer 317608 317608 0 0
Myeloma
Cancer 317609 317609 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An in-house quality audit was conducted at Icon Cancer Centre South Brisbane and Chermside sites in June 2018 which involved a survey that was performed with patients prescribed Denosumab for metastatic breast and prostate cancer which highlighted non-adherence to calcium and vitamin D supplementation. Of the 35 patients surveyed, 60% were compliant with their prescribed therapy. As the use of both calcium and vitamin D supplements are an integral part of patient treatment pathways, further research is needed to identify true rates of compliance by analysing a larger patient group throughout more treatment sites in order to identify areas for improvement and barriers to patient compliance. The study will be expanded from the original audit scope to include patients receiving both RANK-L inhibitors and bisphosphonates for cancer related bone metastasis and also multiple myeloma. Data collection will be carried out over 12 months or until target patient number reached. Patients to complete ONE survey only. Patients will complete e-survey either face-to-face or via email link at home after completing e-consent. Patient's information pertaining to blood results will be collected from most recent blood results (via electronic sourcing in TotalCar), and also from bloods collected at the beginning of their treatment (day 1 of starting bone-resorptive therapy)
Intervention code [1] 318659 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325208 0
- To identify rates of compliance to prescribed calcium and vitamin D supplements. This will be ascertained by completion of survey to be carried out by patients. Survey was developed using prescriber-requested questions and the Morisky Medication Adherence Scale (MMAS-8).
Timepoint [1] 325208 0
Cumulative data will be assessed after all the participants have completed questionnaires and additional data has been completed
Primary outcome [2] 326785 0
To identify barriers to compliance in order to improve on patient care -This will be ascertained by survey responses by patients.
Timepoint [2] 326785 0
Cumulative data will be assessed after all the participants have completed questionnaires and additional data has been completed
Secondary outcome [1] 387180 0
not applicable.
Timepoint [1] 387180 0
not applicable

Eligibility
Key inclusion criteria
Patients over the age of 18 treated at Icon Cancer Centre sites where Denosumab, Pamidronate or Zoledronic acid has been prescribed between August 2021 and recruitment period of 24 months in total or until goal participant numbers have been reached.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with hyperglycemia of malignancy;
Patients with history of osteoporosis.
Patients participating in other clinical trials

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Baseline medical and demographic characteristics will be reported using descriptive summary statistics (mean with standard deviation or median with interquartile range, as appropriate). Medication adherence, based on the results of the MMAS-8 questionnaire, will be scored on an 8-point scale (Morisky et al., 2008); scores of <6, =6 to <8, and 8, will be classified as low, medium and high adherence, respectively. The percentages patients in each adherence category will be presented for the entire cohort as well as for specific sub-groups defined by baseline characteristics.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
12/08/2021
Date of last participant enrolment
Anticipated
1/01/2024
Actual
27/09/2022
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
300
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17609 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [2] 17610 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [3] 17611 0
Icon Cancer Care Southport - Southport
Recruitment hospital [4] 17612 0
Icon Cancer Care Chermside - Chermside
Recruitment postcode(s) [1] 31354 0
4101 - South Brisbane
Recruitment postcode(s) [2] 31355 0
4066 - Auchenflower
Recruitment postcode(s) [3] 31356 0
4215 - Southport
Recruitment postcode(s) [4] 31357 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 306806 0
Charities/Societies/Foundations
Name [1] 306806 0
Icon Cancer Foundation
Country [1] 306806 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Icon Cancer Foundation
Address
Level 1 / 22 Cordellia street, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 307358 0
None
Name [1] 307358 0
Address [1] 307358 0
Country [1] 307358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306961 0
The Bellberry Human Research Ethics Committee
Ethics committee address [1] 306961 0
123 Glen Osmond Road, Eastwood, South Australia 5063
Ethics committee country [1] 306961 0
Australia
Date submitted for ethics approval [1] 306961 0
12/09/2019
Approval date [1] 306961 0
03/10/2019
Ethics approval number [1] 306961 0
2019-07-603

Summary
Brief summary
This observational study will examine rates of compliance with calcium and vitamin D doses prescribed to cancer patients who may benefit from taking these supplements due to the type of cancer treatment drugs they have been given.

Who is it for?
You may be eligible for this study if you are 18 or older, you are receiving cancer treatment(s) including Denosumab, Pamidronate or Zoledronic acid and you are attending one of the Icon Cancer Centres in Queensland for treatment.

Study details
All enrolled participants will be asked to complete a survey that includes questions about their current cancer treatment, and whether they have been prescribed calcium and vitamin D in addition to their cancer treatment. It is expected that the survey will take approximately 15 minutes to complete, and participants will be asked to complete this during a scheduled clinic visit, therefore additional study visits are not required.

It is hoped this research will determine the current rate of calcium and vitamin D dose compliance in patients whose cancer treatment may have a negative impact on their bone health. It is hoped this study will also identify barriers that may make it difficult for patients to maintain their calcium and vitamin D doses and will then be able to make adjustments to address these barriers.
Trial website
Not applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105598 0
A/Prof Jermaine Coward
Address 105598 0
Icon Cancer Centre South Brisbane - 293 Vulture St, South Brisbane QLD 4101
Country 105598 0
Australia
Phone 105598 0
+61459633970
Fax 105598 0
07 3737 4701
Email 105598 0
[email protected]
Contact person for public queries
Name 105599 0
Mrs Ashleigh Smith
Address 105599 0
Icon Cancer Centre Chermside - Chermside Medical Complex, 1/956 Gympie Road, Chermside QLD 4032
Country 105599 0
Australia
Phone 105599 0
+61 7 3737 4500
Fax 105599 0
07 3737 4801
Email 105599 0
[email protected]
Contact person for scientific queries
Name 105600 0
Ms Ashleigh Smith
Address 105600 0
Icon Cancer Centre Chermside - Chermside Medical Complex, 1/956 Gympie Road, Chermside QLD 4032
Country 105600 0
Australia
Phone 105600 0
+61 7 3737 4500
Fax 105600 0
07 3737 4801
Email 105600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.