Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001267640
Ethics application status
Approved
Date submitted
18/11/2014
Date registered
3/12/2014
Date last updated
17/09/2023
Date data sharing statement initially provided
3/04/2023
Date results provided
3/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase II study evaluating a decision aid for women considering neoadjuvant systemic therapy for operable invasive breast cancer (ANZ 1301 DOMINO)
Scientific title
Women who are considering neoadjuvant systemic therapy for operable invasive breast cancer will evaluate the utility and feasibility of a decision aid to help them make their treatment decision (ANZ 1301 DOMINO)
Secondary ID [1] 285226 0
ANZ 1301
Universal Trial Number (UTN)
Trial acronym
DOMINO
Linked study record
ACTRN12613000658718

Health condition
Health condition(s) or problem(s) studied:
Operable invasive breast cancer 292855 0
Neoadjuvant systemic therapy 292856 0
Condition category
Condition code
Cancer 293156 293156 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible women will be offered a custom-designed decision aid focussed on the decision about neoadjuvant therapy. An assessment will be made of its utility and acceptability for patients and clinicians.

The content of the Decision Aid is based on the DOMINO survey results (ANZ 1301 DOMINO Project 1: Exploring decision making about neoadjuvant chemotherapy for women with operable breast cancer; ACTRN12613000658718), including information delivery preferences and factors considered by patients to be relevant to their decision.

Participants will access the Decision Aid online via a link in an email sent to them by the BCT when they register for the study (registration is also online). The Decision Aid will take approximately 30 minutes to read; it can be downloaded and printed if required.

Participants will also complete a series of online questionnaires at 4 different timepoints over a 12 month period:
1) Before participants read the Decision Aid, a set of questionnaires will ask them how they feel about the treatment options they have been offered. These will take about 5-10 minutes to complete.
2) After participants see their medical oncologist and make their treatment decision. The questionnaires will ask them how they feel about the treatment decision they have made. It will take about 15-20 minutes to complete.
3) After the first part of their treatment (after neoadjuvant chemotherapy and before surgery, or after surgery and before chemotherapy). The questionnaires will ask them how they feel about their treatment decision and will take about 10-15 minutes to complete.
4) Twelve months after registration to the study, questionnaires will ask how they feel about participants' treatment decision and will take about 10-15 minutes to complete.

A selected number of participants who consent to a telephone interview will be contacted by researchers to understand individual women's experiences using the Decision Aid. The telephone interview is optional.

Investigators will also be contacted via an online survey and telephone interview to discuss the Decision Aid acceptability and feasibility of use in routine clinical practice.
Intervention code [1] 290102 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293014 0
Decision Aid acceptability to patients, assessed using an online questionnaire (Decision Aid Feedback) and telephone interview for selected patients.
Timepoint [1] 293014 0
within 6 weeks of accessing the Decision Aid
Primary outcome [2] 293682 0
Decision Aid acceptability to Investigators, assessed online by all investigators using the "Investigator-reported acceptability and feasibility survey" and a telephone interview (if required)
Timepoint [2] 293682 0
After the last patient is registered
Primary outcome [3] 293683 0
Decision Aid feasibility, , assessed online by all investigators using the "Investigator-reported acceptability and feasibility survey" and a telephone interview (if required)
Timepoint [3] 293683 0
After the last patient is registered
Secondary outcome [1] 310146 0
Change in decisional conflict before and after administration of the Decision Aid
Timepoint [1] 310146 0
Changes in the Decision Conflict Scale from the Pre-DA Assessment to the Post-Treatment-Decision Assessment
Secondary outcome [2] 310147 0
Patient knowledge of Decision Aid contents
Timepoint [2] 310147 0
Measured at Treatment Decision using the Knowledge of DA Information questionnaire
Secondary outcome [3] 310148 0
Information involvement preference
Timepoint [3] 310148 0
Measured using the Decision Making Preference questionnaire (DMPQ) and Information and Involvement Preferences scale. Changes will be evaluated from the Information the Pre-DA Assessment to the Post-Treatment Decision Assessment
Secondary outcome [4] 310149 0
Correlation between preferred and achieved decision control
Timepoint [4] 310149 0
Agreement in decision control as measured by the Decision Making Preference Questionnaire to determine whether the preferred involvement changed pre-DA (before reading the DA) to post-DA (after reading the DA)
Secondary outcome [5] 310150 0
Change in anxiety before and after use of Decision Aid
Timepoint [5] 310150 0
Changes in anxiety from the baseline assessment will be calculated by subtracting the baseline STAI-6 Anxiety score from the follow-up assessments
Secondary outcome [6] 310151 0
Change in fear of breast cancer progression
Timepoint [6] 310151 0
Changes in fear of recurrence from Post-Treatment-Decision-Assessment to Post-Treatment (after surgery (neoadjuvant therapy) or after chemotherapy (adjuvant therapy)) measured by the Fear of Progression questionnaire
Secondary outcome [7] 310152 0
Change in decisional regret
Timepoint [7] 310152 0
Measured by the Decisional Regret Scale from after completing treatment (after chemotherapy for adjuvant patients; after surgery for neoadjuvant patients) to the Post-Treatment Assessment at 12 months
Secondary outcome [8] 310154 0
Cost of Decision Aid use in the clinical setting
Timepoint [8] 310154 0
Average cost calculated after treatment completed, calculated using pharmaceutical benefits scheme and medical benefits items and a comparison made between those who chose neoadjuvant systemic therapy and those who chose surgery first.

Eligibility
Key inclusion criteria
1. Female, aged >= 18 years
2. A histological diagnosis of operable invasive breast cancer
3. Participants are being considered for neoadjuvant systemic (chemo- or endocrine) therapy as a treatment option with curative intent
4. Signed Screening Consent; patient agrees and is able to access information to study via the internet; willing and able to comply with the protocol assessments (questionnaires) for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than 3 months duration of neoadjuvant systemic therapy is planned
2. Hearing or other impairment that would preclude a telephone interview
3. Unable to access the internet using a laptop or desktop computer, or does not have an active email address to participate in the study
4. Insufficient English language skills for participation in written surveys and oral interviews
5. Inflammatory, metastatic or inoperable breast cancer
6. Patients considered to have a medical or psychiatric condition that prohibits obtaining informed consent

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2015
Actual
17/06/2015
Date of last participant enrolment
Anticipated
1/08/2016
Actual
17/09/2016
Date of last data collection
Anticipated
17/09/2017
Actual
12/10/2017
Sample size
Target
50
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 3464 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 3465 0
Mater Sydney - North Sydney
Recruitment hospital [3] 3466 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 3929 0
Breast and Endocrine Centre - Gateshead
Recruitment postcode(s) [1] 9843 0
2298 - Waratah
Recruitment postcode(s) [2] 9844 0
2060 - North Sydney
Recruitment postcode(s) [3] 9845 0
3052 - Parkville
Recruitment postcode(s) [4] 9846 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 289838 0
Other Collaborative groups
Name [1] 289838 0
Breast Cancer Trials
Country [1] 289838 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 288793 0
Charities/Societies/Foundations
Name [1] 288793 0
HCF Research Foundation
Address [1] 288793 0
PO Box 4242
Sydney NSW 2001
Country [1] 288793 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291571 0
Hunter New England Research Ethics & Governance Unit
Ethics committee address [1] 291571 0
Ethics committee country [1] 291571 0
Australia
Date submitted for ethics approval [1] 291571 0
28/11/2014
Approval date [1] 291571 0
30/01/2015
Ethics approval number [1] 291571 0
14/12/10/4.05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50946 0
Dr Nicholas Zdenkowski
Address 50946 0
Breast and Endocrine Centre
6-8 Sydney Street
Gateshead NSW 2292
Country 50946 0
Australia
Phone 50946 0
+61 2 4942 2600
Fax 50946 0
Email 50946 0
nick.zdenkowski@newcastle.edu.au
Contact person for public queries
Name 50947 0
Corinna Beckmore
Address 50947 0
BCT
PO Box 283
The Junction NSW 2291
Country 50947 0
Australia
Phone 50947 0
+61 2 4925 5235
Fax 50947 0
Email 50947 0
corinna.beckmore@bctrials.org.au
Contact person for scientific queries
Name 50948 0
Nicholas Zdenkowski
Address 50948 0
Breast and Endocrine Centre
6-8 Sydney Street
Gateshead NSW 2292
Country 50948 0
Australia
Phone 50948 0
+61 2 4942 2600
Fax 50948 0
Email 50948 0
nick.zdenkowski@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial.
When will data be available (start and end dates)?
Data will be made available for request after publication of the main/final study results; no end date.

Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.
Available to whom?
Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Subject to approval by Breast Cancer Trials concept@bctrials.org.au (refer to BCT Data Sharing Guidelines).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18777Other https://researchdata.edu.au/health/view/2538168  Please refer to BCT Data Sharing Guidelines attach... [More Details] 366972-(Uploaded-18-08-2023-13-54-21)-Study-related document.pdf
20369Study protocol https://doi.org/10.58080/2tcr-3d52 


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExploring women's experiences with a decision aid for neoadjuvant systemic therapy for operable breast cancer.2018https://dx.doi.org/10.1002/hsr2.13
EmbaseSingle-arm longitudinal study to evaluate a decision aid for women offered Neoadjuvant systemic therapy for operable breast cancer.2018https://dx.doi.org/10.6004/jnccn.2017.7063
EmbasePatient-reported outcomes with neoadjuvant vs adjuvant systemic therapy for operable breast cancer.2019https://dx.doi.org/10.1016/j.breast.2019.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.