Metastatic Breast Cancer Treatment Planning

NCT03127332 | Withdrawn

• 1 other identifier: G413
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overarching objective of this study is to close clinical knowledge and performance gaps by providing oncology clinicians with the latest advances and emerging research in the evidence-based and personalized treatment of metastatic breast cancer patients. In addition, the research team seeks to meet quality measures relevant to value-based care delivery through IT infrastructure and clinical workflow processes. The research team also hopes to gain insights into clinician practice patterns related to metastatic breast cancer, and the correlation between the reported goals of care for patients with metastatic breast cancer, and the patients' fit/frailty status and treatment decisions.

Conditions

Metastatic Breast Cancer

Keywords

Treatment care planning

Outcome Measures

Primary Outcomes (1)

• Adherence (by providers) to evidence-based treatment recommendations for patients with metastatic breast cancer.

  Data collected on the Carevive CPS will be analyzed in order to correlate evidence-based guidelines to individual practice patterns

  Year 1

Secondary Outcomes (2)

• Number of patients who are fit, intermediate fit, or frail as assessed by a modified geriatric assessment and a description of the chemotherapy regimens they are prescribed

  Year 1

• ER utilization and hospitalization in elderly patients with metastatic breast cancer

  Year 1

Interventions

Carevive CPS OTHER

This intervention will focus on the use of the Carevive CPS at the point of treatment decision making, enabling providers to deliver evidence-based and personalized treatment care plans to their metastatic breast cancer patients on active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and generated by clinical staff and/or peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: No, gender identity is not based on self-representation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• diagnosis of metastatic breast cancer
• newly diagnosed or needing a new line of therapy and have not yet made a treatment decision
• able to understand English

You may not qualify if:

• any patient who cannot understand English
• any prisoner and/or other vulnerable person as defined by NIH (45 CFR 46, Subpart B, C, and D)

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 25, 2017
• Study Start: July 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share