A phase II study evaluating a decision aid for women considering neoadjuvant systemic therapy for operable invasive breast cancer (ANZ 1301 DOMINO)
Breast Cancer Trials (BCT)Dataset description
* 51 eligible women * Offered a custom-designed DA focussed on the decision about neoadjuvant systemic therapy. * An assessment will be made of its utility and acceptability for patients and investigators using measures: • Decision Aid Feedback • Decision Conflict Scale • STAI-6 • DMPQ • Information and Involvement Preferences • Knowledge of Decision Aid Information • Satisfaction With Decision Scale • Preferred and Achieved Decision Control (first and second part of the DMPQ) • FOP 12 • Distress Thermometer • EQ-5D-5L (optional). The content of the DA 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.Identifiers
Source Study
Trial name (public)
A phase II study evaluating a decision aid for women considering neoadjuvant systemic therapy for operable invasive breast cancer (ANZ 1301 DOMINO)Trial acronym
DOMINO
Trial ID
ACTRN12614001267640
Purpose
Treatment
Phase
Phase 2
Funding
Other Collaborative groups,Breast Cancer Trials
Scientific enquiries
Dr Nicholas Zdenkowski
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 c .... Read more
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.
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 condit .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 59
Min. age 18 Years
Max. age No limit
Sex Females
Condition category Neoadjuvant systemic therapy , Operable invasive breast cancer
Condition code Cancer
Intervention
Intervention code Treatment: Other
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 .... Read more
Comparison
Control group Uncontrolled
No control group
Outcomes
Outcome: Decision Aid acceptability to patients, assessed using an online questionnaire (Decision Aid Feedback) and telephone interview for selected patients.Timepoint: within 6 weeks of accessing the Decision Aid
Outcome: 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: After the last patient is registered
Outcome: Decision Aid feasibility, , assessed online by all investigators using the "Investigator-reported acceptability and feasibility survey" and a telephone interview (if required)Timepoint: After the last patient is registered
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial.
When will data be available?
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.