Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:June 27, 2017
End Date:December 31, 2018

Use our guide to learn which trials are right for you!

Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).

Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions
will be used to identify factors that influence decision-making in treatment selection and
the optimal approach for sharing information about prognosis and guideline-based care.
Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct
semi-structured interviews/discussion groups with patients, navigators, nurses, and
physicians to elements important to decision-making.

Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically
develop the TP intervention using the Ottawa Decision Support Framework. Investigators will
test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an
iterative process.

Investigators will use patient interviews and navigator, nurse, and physician focus group
discussions to identify factors that influence decision-making in treatment selection and the
optimal approach for sharing information about prognosis and guideline-based care. Patients
will be recruited from the medical oncology clinic. Patients will be identified by their
primary oncologist. All eligible patient will be provided with a study information flyer. All
patient participants will be asked to provide written informed consent prior to participation
in interviews; provider participants will be provided with Information sheets prior to focus
groups by a research coordinator. Participants in Group 1 will be asked to complete a
demographic form. The demographic forms for patients, navigators, nurses, and medical
oncologists are included in Appendix B. Demographic form will include questions about your
age, sex, race and education. The demographic form will take 5 minutes to complete. At study
entry, descriptive data including patient demographics (age, sex, race), breast cancer
characteristics (subtype, line of therapy, specific treatment offered, prior treatments
received), physician will be collected to provide clinical context for the analysis. The
patients will be interviewed at the patient's next appointment (either with the physician or
in the infusion center) or the patients can schedule to come on an off clinic day of their
preference. The study coordinators will offer each patient the option to complete the consent
form at home. If they decide to complete the consent form at home investigators will follow
up with by contacting them on the telephone to ensure that the consent form was completed and
to confirm their interview at their next clinic visit or an off day of their preference. This
30 minute to an hour interview will take place in a private meeting room within the UAB
Comprehensive cancer center. The patient interviews will be audio-recorded by using a digital
audio recorder.

For Group 2, patients will be recruited from the medical oncology clinic. Patients will be
identified by their primary oncologist. A trained research coordinator will consent the
patient during a routine clinic visit. This group will consist of 5 new patients who did not
participate in Group 1 patient interviews. Descriptive data including patient name and
medical record number will be collected on a tracking sheet. No other personal identifiable
information will be collected. This 30-minute interview will take place in the clinic room or
a private room within the UAB Comprehensive cancer center (based on patient preference). The
researcher will provide the patient with the iPad for completion of baseline patient-reported
outcome questionnaires using the Carevive® platform for a test patient in a test environment
which will not be linked to the patient's medical record. The intervention questionnaire will
include standard questions used to routine treatment planning at UAB/MCI as well as any
study-specific questions generated from Phase I above. This will allow feedback on the
questionnaire itself. The research coordinator will then provide the patient with an example
TP that includes responses to the questionnaire. The study PI will review the electronic or a
printed version with the patient to get feedback on the acceptability of the TP, content of
the TP, and the best approach to utilizing the TP. This process may be modified based on
results of our qualitative analysis.

Investigators will conduct separate focus groups with each provider group. This will include
7 breast medical oncologists, 10 patient navigators, and 10 nurses (5 clinic nurses who work
directly with the breast oncologists and 5 infusion nurses).

Inclusion Criteria:

- 1. Women with age ≥ 18

- 2. Presence of MBC

- 3. Patients may be receiving any line and type of therapy including both standard of
care and clinical trials.

Exclusion Criteria:

- 1. Patient who are not able to read and/or speak English

- 2. Patients with a life expectancy less than 3 months

- 3. Patients unable to provide informed consent

- 4. Men
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Gabrielle B Rocque, MD
Phone: 205-934-5287
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials