Decision Making ,SharedNCT03248258
Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)
An observational study of Decision Making ,Shared and De-escalation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP). Phase 1: 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Making ,Shared, De-escalation
- What is being tested?
- Qualitative Interview or Focus group discussions
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic and Early stage Breast Cancer patients receiving care at UAB Hematology/Oncology Kirklin Clinic. Breast Cancer Patient advocates, oncology nurses, navigators, and Oncology Physicians
Who may be able to join
- 1. Women with age ≥ 18
- 2. Presence of Metastatic Breast Cancer or Early Stage Breast Cancer
- 3. Patients may be receiving any line and type of therapy including both standard of care and clinical trials.
- 1. Providers who are self-identified patient advocates working with breast cancer researchers
- Providers who have direct contact with breast cancer patients
Who cannot join
- 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
- Patient Advocates (Phase III)
- None
Show all 9Show fewer
- Sampling: We will conduct interviews with 10-20 patient advocates for phase 3 of this project.
- Provider (navigator, nurse, physician) (Pjhase I, III)
- 2. None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).
Phase 1:
Read more
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.
Phase 2:
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.
Phase 3:Further explore decision-making related to reducing amount of chemotherapy for patients with good prognosis.
Read the detailed description
Phase 1:
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.
Phase 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).
Phase 3:
The purpose of this phase is to (1) further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial). This study will include both patients and patient advocates, who bring a broad perspective to how the patient experience should be considered in research. Interviews with patients, patient advocates, and physicians will be conducted either in person or by phone/zoom based on patient preference. In person patient interviews will be conducted (1) in the UAB Medical Oncology outpatient clinic rooms or in private room in the UAB Comprehensive Cancer Center (based on patient preference for location). In person patient advocate or physician interviews will be conducted at in-person meetings of the Eastern Cooperative Group, which are routinely attended by the patient advocates and physicians in the private room or location of the advocate's choice.
- Conditions
- Decision Making ,Shared, De-escalation
- Being tested
- Qualitative Interview or Focus group discussions
- Keywords
- Metastatic Breast Cancer, Treatment Decision Making, Shared Decision Making, Early Stage Breast Cancer, De-escalation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Interview or Focus group discussionsOther
The purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care.
Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial).
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Interview Participants - Shared Decision Making | Metastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions | |
| Early Stage Breast Interview Participants - Shared Decision Making | Early Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions | |
| Provider Focus Group -Shared Decision Making | Clinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator. Receives: Other: Qualitative Interview or Focus group discussions | |
| Non-UAB Provider Shared Decision Making | Non-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions | |
| Early Stage de-escalation Interview Participants | Early Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions | |
| Patient Advocate de-escalation Interview Participants | Patient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions | |
| Physician de-escalation Interview Participants | Physician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions | |
| Early Stage Feedback Interview Participants | Early Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer. Receives: Other: Qualitative Interview or Focus group discussions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making
Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.
Measured: 3 years
Concept of de-escalation
Patients reduce the amount of chemotherapy to avoid side effects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start27 Jun 2017
- Primary completion20 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision Making ,SharedStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Gabrielle Rocque, University of Alabama at Birmingham
- Investigators
- Gabrielle B Rocque, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248258
- Sponsor's protocol ID
- IRB-170518009
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2017
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocque GB, Andrews C, Lawhon VM, Ingram SA, Frazier RM, Smith ML, Wagner LI, Zubkoff L, Wallner LP, Wolff AC. Physician Perspectives on Reducing Curative Cancer Treatment Intensity for Populations Underrepresented in Clinical Trials. Oncologist. 2022 Dec 9;27(12):1067-1073. doi: 10.1093/oncolo/oyac191.
PubMed 36215065
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)
- ClinicalTrials.gov ID
- NCT03248258
- Acronym / sponsor ID
- IRB-170518009
- Conditions
- Decision Making ,Shared, De-escalation
- Keywords
- Metastatic Breast Cancer, Treatment Decision Making, Shared Decision Making, Early Stage Breast Cancer, De-escalation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).
Phase 1:
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.
Phase 2:
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.
Phase 3:Further explore decision-making related to reducing amount of chemotherapy for patients with good prognosis.
Detailed description
Phase 1:
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.
Phase 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).
Phase 3:
The purpose of this phase is to (1) further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial). This study will include both patients and patient advocates, who bring a broad perspective to how the patient experience should be considered in research. Interviews with patients, patient advocates, and physicians will be conducted either in person or by phone/zoom based on patient preference. In person patient interviews will be conducted (1) in the UAB Medical Oncology outpatient clinic rooms or in private room in the UAB Comprehensive Cancer Center (based on patient preference for location). In person patient advocate or physician interviews will be conducted at in-person meetings of the Eastern Cooperative Group, which are routinely attended by the patient advocates and physicians in the private room or location of the advocate's choice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Interview Participants - Shared Decision Making | – | Other: Qualitative Interview or Focus group discussionsMetastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer. |
| Early Stage Breast Interview Participants - Shared Decision Making | – | Other: Qualitative Interview or Focus group discussionsEarly Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer. |
| Provider Focus Group -Shared Decision Making | – | Other: Qualitative Interview or Focus group discussionsClinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator. |
| Non-UAB Provider Shared Decision Making | – | Other: Qualitative Interview or Focus group discussionsNon-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer. |
| Early Stage de-escalation Interview Participants | – | Other: Qualitative Interview or Focus group discussionsEarly Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer. |
| Patient Advocate de-escalation Interview Participants | – | Other: Qualitative Interview or Focus group discussionsPatient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer. |
| Physician de-escalation Interview Participants | – | Other: Qualitative Interview or Focus group discussionsPhysician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer. |
| Early Stage Feedback Interview Participants | – | Other: Qualitative Interview or Focus group discussionsEarly Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic and Early stage Breast Cancer patients receiving care at UAB Hematology/Oncology Kirklin Clinic. Breast Cancer Patient advocates, oncology nurses, navigators, and Oncology Physicians
Key inclusion criteria (5 listed)
- 1. Women with age ≥ 18
- 2. Presence of Metastatic Breast Cancer or Early Stage Breast Cancer
- 3. Patients may be receiving any line and type of therapy including both standard of care and clinical trials.
- 1. Providers who are self-identified patient advocates working with breast cancer researchers
- Providers who have direct contact with breast cancer patients
Key exclusion criteria (9 listed)
- 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
- Patient Advocates (Phase III)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative Interview or Focus group discussionsThe purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial). | Other | Early Stage Breast Interview Participants - Shared Decision Making, Early Stage Feedback Interview Participants, Early Stage de-escalation Interview Participants, Metastatic Breast Interview Participants - Shared Decision Making, Non-UAB Provider Shared Decision Making, Patient Advocate de-escalation Interview Participants, Physician de-escalation Interview Participants, Provider Focus Group -Shared Decision Making |
Primary outcome
Shared Decision Making
Time frame: 3 years
Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.
Concept of de-escalation
Time frame: 2 years
Patients reduce the amount of chemotherapy to avoid side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 36215065Rocque GB, Andrews C, Lawhon VM, Ingram SA, Frazier RM, Smith ML, Wagner LI, Zubkoff L, Wallner LP, Wolff AC. Physician Perspectives on Reducing Curative Cancer Treatment Intensity for Populations Underrepresented in Clinical Trials. Oncologist. 2022 Dec 9;27(12):1067-1073. doi: 10.1093/oncolo/oyac191.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle B Rocque, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decision Making ,Shared and De-escalation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.