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NCT03806738 · ClinicalTrials.gov registry record · NA
Enhancing Shared Decision-Making in Breast Cancer
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
NCT03806738 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 140 participants.
The verdict
NCT03806738, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
Study 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. 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.
Interventions
- OTHER Intervention-specific Carevive questionnaire
- OTHER Standard of Care questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03806738
The ClinicalTrials.gov registry entry for NCT03806738 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intervention-specific Carevive questionnaire is the first listed.
NCT03806738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03806738 about?
NCT03806738 is a clinical study titled "Enhancing Shared Decision-Making in Breast Cancer". 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...
What is the current status of trial NCT03806738?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2018-12-11. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03806738?
The interventions under investigation include: Intervention-specific Carevive questionnaire (OTHER), Standard of Care questionnaire (OTHER).
Who is sponsoring clinical trial NCT03806738?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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