A phase II study evaluating a decision aid for women considering neoadjuvant systemic therapy for operable invasive breast cancer (ANZ 1301 DOMINO)
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)
Breast Cancer Trials
50 participants
Jun 17, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- Female, aged >= 18 years
- A histological diagnosis of operable invasive breast cancer
- Participants are being considered for neoadjuvant systemic (chemo- or endocrine) therapy as a treatment option with curative intent
- 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.
Exclusion Criteria6
- Less than 3 months duration of neoadjuvant systemic therapy is planned
- Hearing or other impairment that would preclude a telephone interview
- Unable to access the internet using a laptop or desktop computer, or does not have an active email address to participate in the study
- Insufficient English language skills for participation in written surveys and oral interviews
- Inflammatory, metastatic or inoperable breast cancer
- Patients considered to have a medical or psychiatric condition that prohibits obtaining informed consent
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Interventions
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.
Locations(4)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614001267640