Shared Decision MakingNCT03806738
Enhancing Shared Decision-Making in Breast Cancer
A study testing Intervention-specific Carevive questionnaire in people with Shared Decision Making, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Shared Decision Making
- What is being tested?
- Intervention-specific Carevive questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 31 Dec 2022
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age ≥ 18
- Presence of breast cancer
- Receiving any line and type of therapy (including both standard of care and clinical trials)
Who cannot join
- Patients who are not able to read and/or speak English
- Patients who are not being offered any medical therapy (hormone therapy, chemotherapy, targeted therapy) for their breast cancer
- Patients with a life-expectancy of less than 3 months
- Patients unable to provide informed consent
- Men
- Patients who do not plan to receive treatment at UAB or MCI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our primary outcome will be the increase in percentage of patients reporting a perception of shared decision-making.
Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making.
Read more
Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the percentage of providers perceiving SDM with the patient, number of treatment options offered to patients, the proportion of times that clinical trials are offered to patients, the use of NCCN guideline-based treatment, and self-report of treatment plan use.
Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether providers elicit: any patient preferences during treatment planning, preferences related to physical side effects or efficacy, or preferences related to other aspects of the patient experience. We will also assess whether providers use the TP in the decision-making discussion and whether providers discuss or offer clinical trials to the patient.
Read the detailed description
Two sites (UAB and MCI) will conduct the RCT of 140 patients with MBC and 140 patients with EBC comparing use of SDM TPs delivered during decision-making visits compared to TPs delivered post-decision-making. The Carevive Care Planning System (CPS) treatment planning software will be used at all clinical sites to provide treatment care plans to patients with breast cancer. This software platform, which is currently utilized after decision-making, will be modified within this project to facilitate SDM through the creation of a SDM TP utilized during decision-making. Together, the patients and physician will be able to review the patient's decision-making style, patient's desire for prognostic information treatments, and patient preferences about decision-making.
Participants will be compensated in the form of a $20 gift card at the time of consent. After the patient provides consent, the research coordinator will evaluate the electronic medical record (EMR) for completion of standard of care elements necessary for the generation of TPs. At UAB, an embedded form with the necessary information for TP generation is completed in the EMR as part of standard of care by clinical providers. If this form has not been completed, the research coordinator may either notify the provider to initiate form completion or complete this form within the EMR to ensure availability at the time of the treatment decision. If the research coordinator completes this form, it will be reviewed by a clinical provider. The completion of the form prior to consent for patients approached by telephone will be necessary to allow new patients to receive TPs if a decision is made at their initial visit. For other sites who do not use EMR forms, the clinical information will be entered directly into the Carevive platform by either the research coordinators or clinical staff.
We will survey patients as described above on an iPad using the Carevive platform at baseline and every 6 months until a treatment decision is made (intervention or standard-of-care). Post-treatment surveys will be administered using a REDCap survey. To minimize participant burden, we will allow patients to complete surveys in-person during routine clinic visits, by telephone, or at home using an e-mailed link to the survey based on patient preference. To accommodate patients who would like to complete surveys in-person, we will allow for a 1-month window around the initial 6-month survey (for those without a treatment decision within 6 months) and a 2-week window around post-treatment survey. We will record if surveys are completed by email, telephone, or in-person.After each decision-making encounter, the physician will be asked to complete a patient-specific survey in REDCap. For standard of care patients, this will include the Control Preferences Scale. For intervention patients, the survey will include both the Control Preferences Scale and three study-specific questions about use of TP during decision-making.
- Conditions
- Shared Decision Making
- Being tested
- Intervention-specific Carevive questionnaire, Standard of Care questionnaire
- Keywords
- Metastatic Breast Cancer, Treatment Decision Making, Shared Decision Making
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-specific Carevive questionnaireOther
includes standard of care questions with additional decision-making questions
Standard of Care questionnaireOther
includes the standard of care questions that are already in place for Carevive questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making Questionnaire | Experimental | * Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.
* One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap. Receives: Other: Intervention-specific Carevive questionnaire |
| Standard of Care Questionnaire | Other | * Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made.
* One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap. Receives: Other: Standard of Care questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Shared Decision Making
Impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start11 Dec 2018
- Primary completion31 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 Shared Decision MakingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP. Patients randomized to standard of care will receive their standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months until a treatment decision is made.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Carevive Systems, Inc.
- Responsible party
- Principal investigator, Gabrielle Rocque, University of Alabama at Birmingham
- Investigators
- Gabrielle B Rocque, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806738
- Sponsor's protocol ID
- 427 BC SDM
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2019
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocque GB, Eltoum N, Caston NE, Williams CP, Oliver MM, Moradi L, Ingram S, Azuero A, Pisu M, Bhatia S. A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC. Breast Cancer Res Treat. 2024 Aug;206(3):483-493. doi: 10.1007/s10549-024-07304-y. Epub 2024 Jun 10.
PubMed 38856885
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Shared Decision-Making in Breast Cancer
- ClinicalTrials.gov ID
- NCT03806738
- Acronym / sponsor ID
- 427 BC SDM
- Conditions
- Shared Decision Making
- Keywords
- Metastatic Breast Cancer, Treatment Decision Making, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Carevive Systems, Inc.
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Jan 2019 (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.
The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our primary outcome will be the increase in percentage of patients reporting a perception of shared decision-making.
Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making.
Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the percentage of providers perceiving SDM with the patient, number of treatment options offered to patients, the proportion of times that clinical trials are offered to patients, the use of NCCN guideline-based treatment, and self-report of treatment plan use.
Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether providers elicit: any patient preferences during treatment planning, preferences related to physical side effects or efficacy, or preferences related to other aspects of the patient experience. We will also assess whether providers use the TP in the decision-making discussion and whether providers discuss or offer clinical trials to the patient.
Detailed description
Two sites (UAB and MCI) will conduct the RCT of 140 patients with MBC and 140 patients with EBC comparing use of SDM TPs delivered during decision-making visits compared to TPs delivered post-decision-making. The Carevive Care Planning System (CPS) treatment planning software will be used at all clinical sites to provide treatment care plans to patients with breast cancer. This software platform, which is currently utilized after decision-making, will be modified within this project to facilitate SDM through the creation of a SDM TP utilized during decision-making. Together, the patients and physician will be able to review the patient's decision-making style, patient's desire for prognostic information treatments, and patient preferences about decision-making.
Participants will be compensated in the form of a $20 gift card at the time of consent. After the patient provides consent, the research coordinator will evaluate the electronic medical record (EMR) for completion of standard of care elements necessary for the generation of TPs. At UAB, an embedded form with the necessary information for TP generation is completed in the EMR as part of standard of care by clinical providers. If this form has not been completed, the research coordinator may either notify the provider to initiate form completion or complete this form within the EMR to ensure availability at the time of the treatment decision. If the research coordinator completes this form, it will be reviewed by a clinical provider. The completion of the form prior to consent for patients approached by telephone will be necessary to allow new patients to receive TPs if a decision is made at their initial visit. For other sites who do not use EMR forms, the clinical information will be entered directly into the Carevive platform by either the research coordinators or clinical staff.
We will survey patients as described above on an iPad using the Carevive platform at baseline and every 6 months until a treatment decision is made (intervention or standard-of-care). Post-treatment surveys will be administered using a REDCap survey. To minimize participant burden, we will allow patients to complete surveys in-person during routine clinic visits, by telephone, or at home using an e-mailed link to the survey based on patient preference. To accommodate patients who would like to complete surveys in-person, we will allow for a 1-month window around the initial 6-month survey (for those without a treatment decision within 6 months) and a 2-week window around post-treatment survey. We will record if surveys are completed by email, telephone, or in-person.After each decision-making encounter, the physician will be asked to complete a patient-specific survey in REDCap. For standard of care patients, this will include the Control Preferences Scale. For intervention patients, the survey will include both the Control Preferences Scale and three study-specific questions about use of TP during decision-making.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP. Patients randomized to standard of care will receive their standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months until a treatment decision is made.
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making Questionnaire | Experimental | Other: Intervention-specific Carevive questionnaire* Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP. * One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap. |
| Standard of Care Questionnaire | Other | Other: Standard of Care questionnaire* Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made. * One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women age ≥ 18
- Presence of breast cancer
- Receiving any line and type of therapy (including both standard of care and clinical trials)
Key exclusion criteria (6 listed)
- Patients who are not able to read and/or speak English
- Patients who are not being offered any medical therapy (hormone therapy, chemotherapy, targeted therapy) for their breast cancer
- Patients with a life-expectancy of less than 3 months
- Patients unable to provide informed consent
- Men
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 |
|---|---|---|
| Intervention-specific Carevive questionnaireincludes standard of care questions with additional decision-making questions | Other | Shared Decision Making Questionnaire |
| Standard of Care questionnaireincludes the standard of care questions that are already in place for Carevive questionnaires | Other | Standard of Care Questionnaire |
Primary outcome
Impact of Shared Decision Making
Time frame: 3 years
Impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making
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 5 Jan 2023.
- Derived from this study: PubMed 38856885Rocque GB, Eltoum N, Caston NE, Williams CP, Oliver MM, Moradi L, Ingram S, Azuero A, Pisu M, Bhatia S. A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC. Breast Cancer Res Treat. 2024 Aug;206(3):483-493. doi: 10.1007/s10549-024-07304-y. Epub 2024 Jun 10.
- 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
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-specific Carevive questionnaire in people with Shared Decision Making, 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 3 inclusion and 6 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 5 Jan 2023. 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?
Impact of Shared Decision Making (time frame: 3 years). 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 NCT03806738, 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 5 Jan 2023.