Enhancing Shared Decision-Making in Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | December 11, 2018 |
| End Date: | December 2021 |
| Contact: | Stacey A Ingram, MEd |
| Email: | saadewakun@uabmc.edu |
| Phone: | 205-934-5287 |
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.
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.
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.
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.
Inclusion Criteria:
- Women age ≥ 18
- Presence of breast cancer
- Receiving any line and type of therapy (including both standard of care and clinical
trials)
Exclusion Criteria:
- 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
We found this trial at
1
site
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
