Trials / Active Not Recruiting

Active Not RecruitingNCT04549571

Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions

Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 543 (actual)

Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
Sex: Female
Age: —
Healthy volunteers: Not accepted

Summary

This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.

Detailed description

The primary and key secondary objectives of the study: PRIMARY OBJECTIVES: I. To demonstrate that the enhanced iCanDecide (iCanDecide-emotional support enhancement \[ESE\]) intervention is more effective than the standard version (iCanDecide-standard \[S\]) resulting in higher patient knowledge about locoregional treatment risks and benefits. II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about locoregional treatment risks and benefits. SECONDARY OBJECTIVES: I. To demonstrate that the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry. II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry. OUTLINE: This study is a multi-level trial of SHaDES that has two interventions in a factorial or crossed design: 1) an individually randomized patient-level randomized controlled trial (RCT) to evaluate the standard version (iCanDecide-S) vs. a version with innovative emotional support enhancements (iCanDecide-ESE), and 2) a clinic-level stepped-wedge cluster randomized trial to test a Clinician Dashboard (CDB). Twenty-five surgical practices will be recruited for participation. Practices will be randomized to the timing of the CDB intervention, with some practices initiating the CDB intervention right away, while others may initiate the CDB later or perhaps be randomized to "no CDB" period. Clinicians will be asked to use the CDB beginning in the time period to which their practice was randomized and continuing to the end of the study. After registration, clinicians are followed up at 9 and 18 months. After a patient is registered, the patient will be randomized to one of two arms: ARM I: Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration. ARM II: Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration. After study registration, patients are followed up at 4-5 weeks and 9 months. Patients will be enrolled at participating clinics during the full duration of the study and all enrolled patients will receive a version of the decision support tool (iCanDecide-S; iCanDecide-ESE). These patient-level activities are not influenced by the timing of the practice-level randomization to the CDB.

Conditions

Interventions

Type	Name	Description
OTHER	Decision Aid iCanDecide - ESE website	Utilize the iCanDecide - ESE website
OTHER	Decision Aid iCanDecide - S website	Utilize the iCanDecide - S website
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery
OTHER	Interview	Participate in interview
OTHER	Training	Receive training
OTHER	Media Intervention	Utilize the CDB
OTHER	Best Practice	Utilize usual care
OTHER	Survey Administration	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

Start date: 2021-02-16
Primary completion: 2024-05-01
Completion: 2027-01-01
First posted: 2020-09-16
Last updated: 2025-04-02

Locations

27 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04549571. Inclusion in this directory is not an endorsement.