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Trial registered on ANZCTR


Registration number
ACTRN12613000658718
Ethics application status
Approved
Date submitted
31/05/2013
Date registered
17/06/2013
Date last updated
14/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
ANZ 1301 (DOMINO): Exploring decision making about neoadjuvant chemotherapy for operable breast cancer.
Scientific title
ANZ 1301 (DOMINO): Women who have had a diagnosis of invasive breast cancer in the last 5 years and were offered or discussed neoadjuvant chemotherapy as a treatment option, will participate in a telephone questionnaire to identify factors influencing their decisions about neoadjuvant chemotherapy
Secondary ID [1] 282634 0
Nil
Universal Trial Number (UTN)
Trial acronym
DOMINO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Factors influencing decisions regarding neoadjuvant chemotherapy 289185 0
Breast cancer 289329 0
Condition category
Condition code
Cancer 289506 289506 0 0
Breast
Public Health 289670 289670 0 0
Other public health

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

Each participant will do the questionnaire once. The questionnaire will take approximately 30 minutes.

The first few questions are to check that the interview is right for the participant. The next questions are for general information on age, location (postcode only) and some general information about health insurance and where the participant was treated (public or private hospital).
The rest of the questions will ask about:
* Breast cancer diagnosis
* What things the particpant thought about, or might think about, to help them decide whether or not to have chemotherapy before breast cancer surgery
* What treatments the participant had for their breast cancer
* What were their worries and concerns while they were having treatment for breast cancer
* What information women should have, before deciding whether or not to have chemotherapy before breast cancer surgery.

Some questions will have different answers to choose from and others also allow for comments to be made.

Ten to twenty interviews will be conducted to identify the majority of relevant issues. The aim is for issue saturation, where no major new issues are raised in three consecutive interviews.
Intervention code [1] 287181 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289610 0
To identify the information needs for women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable breast cancer by analysing the results of all completed telephone questionnaires
Timepoint [1] 289610 0
At completion of all participant telephone interviews
Primary outcome [2] 289756 0
To identify the issues faced and their prevalence and impact on decision-making for women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable breast cancer by analysing the results of all completed telephone questionnaires
Timepoint [2] 289756 0
At completion of all participant telephone interviews
Primary outcome [3] 289757 0
To identify the level of distress associated with treatment for women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable breast cancer by analysing the results of all completed telephone questionnaires
Timepoint [3] 289757 0
At completion of all participant telephone interviews
Secondary outcome [1] 302854 0
N/A
Timepoint [1] 302854 0
N/A

Eligibility
Key inclusion criteria
1) Participants must be female, >=18 years
2) Participants have had a diagnosis of invasive breast cancer in the last 5 years
3) Participants have been offered, or have discussed, neoadjuvant chemotherapy as a treatment option
4) Participants have completed surgical intervention for breast cancer
5) Participants are capable of giving informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Hearing or other impairment that would preclude a phone interview
2) Insufficient English language skills for participation

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The primary analysis will include all registered participants.
Interviews will be transcribed and analysed thematically using Nvivo (Registered Trademark) qualitative research software. Participants will continue to be enrolled and interviewed until thematic saturation has occurred, indicated by no major new issues being identified in 3 consecutive interviews.
Thematic analysis will involve the researchers reading and re-reading transcripts to identify mutually exclusive themes. Initially two researchers will read five transcripts and code independently. They will then meet to discuss and resolve discrepancies, documenting refined coding rules. A draft thematic structure will be constructed and applied to the remaining transcripts. Where necessary, new themes will be identified and applied retrospectively to transcripts coded earlier. Characteristic quotes illustrating each theme will be identified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287304 0
Other Collaborative groups
Name [1] 287304 0
ANZBCTG
Address [1] 287304 0
PO Box 155
HRMC NSW 2310
Country [1] 287304 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group
Address
PO Box 155
HRMC NSW 2310
Country
Australia
Secondary sponsor category [1] 286056 0
None
Name [1] 286056 0
Address [1] 286056 0
Country [1] 286056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289388 0
Hunter New England HREC
Ethics committee address [1] 289388 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 289388 0
Australia
Date submitted for ethics approval [1] 289388 0
28/06/2013
Approval date [1] 289388 0
17/07/2013
Ethics approval number [1] 289388 0
13/07/17/5.07

Summary
Brief summary
The study aims to identify relevant issues and information needs of women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable cancer, and incorporate them into a prospective questionnaire and decision aid for women diagnosed with operable breast cancer considering neoadjuvant chemotherapy.

Who is it for?
You may be eligible to join this study if you are aged over 18 years, have had a diagnosis of invasive breast cancer in the last 5 years, have been offered or have discussed neoadjuvant chemotherapy as a treatment option and have completed a surgical intervention for breast cancer.

Trial details
Participants in this study will be interviewed once over the phone to identify the issues faced and their prevalence and impact on decision making, and the level of distress associated with treatment for women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable breast cancer. The findings will be incorporated into a prospective questionnaire and subsequent decision aid for women considering neoadjuvant chemotherapy for operable breast cancer.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 40142 0
Dr Nicholas Zdenkowski
Address 40142 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 40142 0
Australia
Phone 40142 0
+61 2 7985 0134
Fax 40142 0
Email 40142 0
enquiries@anzbctg.org
Contact person for public queries
Name 40143 0
Dr Nicholas Zdenkowski
Address 40143 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 40143 0
Australia
Phone 40143 0
+61 2 4985 0134
Fax 40143 0
Email 40143 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 40144 0
Dr Nicholas Zdenkowski
Address 40144 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 40144 0
Australia
Phone 40144 0
+61 2 4985 0134
Fax 40144 0
Email 40144 0
enquiries@anzbctg.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary