ANZCTR - Registration

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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 information initially 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]

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

Neoadjuvant systemic therapy

Condition category

Condition code

Cancer

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Decision Aid acceptability to patients, assessed using an online questionnaire (Decision Aid Feedback) and telephone interview for selected patients.

Timepoint [1]

within 6 weeks of accessing the Decision Aid

Primary outcome [2]

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]

After the last patient is registered

Primary outcome [3]

Decision Aid feasibility, , assessed online by all investigators using the "Investigator-reported acceptability and feasibility survey" and a telephone interview (if required)

Timepoint [3]

After the last patient is registered

Secondary outcome [1]

Change in decisional conflict before and after administration of the Decision Aid

Timepoint [1]

Changes in the Decision Conflict Scale from the Pre-DA Assessment to the Post-Treatment-Decision Assessment

Secondary outcome [2]

Patient knowledge of Decision Aid contents

Timepoint [2]

Measured at Treatment Decision using the Knowledge of DA Information questionnaire

Secondary outcome [3]

Information involvement preference

Timepoint [3]

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]

Correlation between preferred and achieved decision control

Timepoint [4]

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]

Change in anxiety before and after use of Decision Aid

Timepoint [5]

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]

Change in fear of breast cancer progression

Timepoint [6]

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]

Change in decisional regret

Timepoint [7]

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]

Cost of Decision Aid use in the clinical setting

Timepoint [8]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

Calvary Mater Newcastle - Waratah

Recruitment hospital [2]

Mater Sydney - North Sydney

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [4]

Breast and Endocrine Centre - Gateshead

Recruitment postcode(s) [1]

2298 - Waratah

Recruitment postcode(s) [2]

2060 - North Sydney

Recruitment postcode(s) [3]

3052 - Parkville

Recruitment postcode(s) [4]

2290 - Gateshead

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Breast Cancer Trials

Address [1]

PO Box 283
The Junction NSW 2291

Country [1]

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]

Charities/Societies/Foundations

Name [1]

HCF Research Foundation

Address [1]

PO Box 4242
Sydney NSW 2001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Research Ethics & Governance Unit

Ethics committee address [1]

Locked Bag No. 1
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2014

Approval date [1]

30/01/2015

Ethics approval number [1]

14/12/10/4.05

Summary

Brief summary

This study aims to find out if a Decision Aid developed to give women information about neoadjuvant treatment for breast cancer is useful in helping them to make a decision about their treatment.

Who is it for?
You may be eligible to join this study if you are 18 years or over, have operable invasive breast cancer and are considering whether or not to have neoadjuvant treatment for breast cancer. You will need to have access to the internet and a computer or laptop to read the Decision Aid and complete the questionnaires.

Trial Details
Most of this study will be carried out online. If you tell your study doctor that you are interested in the study, you will receive an email with a link to further information about the study and to Consent to participate. You can also consent to participate in a telephone interview, which will take place after participants have accessed the Decision Aid.

If you consent to the study, you will complete a questionnaire (which will take about 15-20 minutes to do). Once this questionnaire is completed, you will be able to access the Decision Aid; it can be viewed online or can be downloaded and printed.

After you see your study doctor and make your decision about your treatment, you will receive another email with a link to another questionnaire (15-20 minutes). This will ask you how useful the Decision Aid is and how you feel about your decision about your treatment.

Another email with a link to more questions (15-20 minutes) will be sent to you after you finish the first part of your treatment (surgery for adjuvant treatment or chemotherapy for neoadjuvant treatment).

A last email will be sent to you with a link to a questionnaire (15-20 minutes) 12 months after you originally registered for the study.

Trial website

www.breastcancertrials.org.au

Trial related presentations / publications

Zdenkowski N, Forbes JF, Butow P, Boyle F ANZBCTG: DOMINO - Exploring decision making about neoadjuvant chemotherapy for operable breast cancer HMRI Conference on Translational Research, Newcastle, Australia 2013; PP40.

Zdenkowski N, Butow PN, Fewster S, Beckmore C, Wells K, Forbes JF, Boyle FM Exploring decision making about neoadjuvant chemotherapy for early breast cancer J Clin Oncol 2014; 32, (suppl; e20578.

Zdenkowski N, Butow P, Fewster S, Beckmore C, Wells K, Forbes J, Boyle F. DOMINO: Exploring decision making about neoadjuvant chemotherapy for operable breast cancer. 2014; MOGA ASM 2014 Poster.

Zdenkowski N, Butow P, Mann GB, Fewster S, Beckmore C, Isaacs R, Boyle FM, on behalf of the ANZBCTG. Neoadjuvant systemic therapy for breast cancer: A survey of Australian and New Zealand (ANZ) specialists. St Gallen 2015 2015; P199.

Zdenkowski N, Butow P, Mann B, Fewster S, Douglas C, Boyle FM. Decisions about neoadjuvant systemic therapy for breast cancer: a survey of Australian and New Zealand specialists. ANZ Journal of Surgery. 2015; 85(11):797-799.

Zdenkowski N, Butow P, Hutchings E, Douglas C, Coll JR, Boyle FM A Decision Aid for Women Considering Neoadjuvant Systemic Therapy for Operable Invasive Breast Cancer: Development and Protocol of a Phase II Evaluation Study (ANZ1301 DOMINO). JMIR Research Protocols 2016;5(2):e88 2016; 5(2):e88.

Zdenkowski N, Butow P, Mann GB, Fewster S, Beckmore C, Isaacs R, Douglas C, Boyle FM. A survey of Australian and New Zealand clinical practice with neoadjuvant systemic therapy for breast cancer. Internal Medicine Journal. 2016; 46(6):677-683.

Zdenkowski N. Decision Aids, Patient Views and Barriers. Asia-Pacific Journal of Clinical Oncology. 2016; 12(Suppl 5), Abstract #66 (oral presentation).

Zdenkowski, Nicholas. Development and testing of a decision aid for women contemplating neoadjuvant systemic therapy for operable breast cancer. Asia-Pacific Journal of Clinical Oncology. 2016; 12(Suppl. S5), Abstract #126.

Zdenkowski N, Herrmann A, Hall A, Boyle FM, Butow P. Women's experiences with a decision aid for neoadjuvant systemic therapy for operable breast cancer. SABCS 2016. 2016; P3-11-02 (poster).

Zdenkowski N, Butow P, Spillane AJ, Douglas C, Beckmore C, Jones M, Boyle FM. Primary Results of a Study to Evaluate a Decision Aid for Women Offered Neoadjuvant Systemic Therapy for Breast Cancer. Annals of Oncology. 2017; 28(Supp5), Abstract 1431P.

Zdenkowski N, Butow P, Boyle FM, on behalf of ANZBCTG. Patient Reported Outcomes According to Receipt of Neoadjuvant or Adjuvant Systemic Therapy for Breast Cancer: Results of a Prospective Longitudinal Study. Controversies in Breast Cancer, 2017 (OR06).

Zdenkowski N, Butow P, Spillane A, Douglas C, Snook K, Jones M, Oldmeadow C, Fewster S, Beckmore C, Boyle FM, and for the Australia and New Zealand Breast Cancer Trials Group. Single-Arm Longitudinal Study to Evaluate a Decision Aid for Women Offered Neoadjuvant Systemic Therapy for Operable Breast Cancer. Journal of the National Comprehensive Cancer Network 2018. 16(4):378-385.

Public notes

Breast Cancer Trials formerly known as Australia & New Zealand Breast Cancer Trials Group.

Contacts

Principal investigator

Name

Dr Nicholas Zdenkowski

Address

Breast and Endocrine Centre
6-8 Sydney Street
Gateshead NSW 2292

Country

Australia

Phone

+61 2 4942 2600

Fax

[email protected]

Contact person for public queries

Name

Ms Corinna Beckmore

Address

BCT
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4925 5235

Fax

[email protected]

Contact person for scientific queries

Name

Dr Nicholas Zdenkowski

Address

Breast and Endocrine Centre
6-8 Sydney Street
Gateshead NSW 2292

Country

Australia

Phone

+61 2 4942 2600

Fax

[email protected]

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 [email protected] (refer to BCT Data Sharing Guidelines).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18777	Other		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
20369	Study protocol		https://doi.org/10.58080/2tcr-3d52

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Zdenkowski N, Butow P, Spillan A, Douglas C, Snook... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Single-arm longitudinal study to evaluate a decision aid for women offered Neoadjuvant systemic therapy for operable breast cancer.	2018	https://dx.doi.org/10.6004/jnccn.2017.7063
Embase	Exploring women's experiences with a decision aid for neoadjuvant systemic therapy for operable breast cancer.	2018	https://dx.doi.org/10.1002/hsr2.13
Embase	Patient-reported outcomes with neoadjuvant vs adjuvant systemic therapy for operable breast cancer.	2019	https://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.

Trial Review

Documents added manually

Documents added automatically