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Clinical Trials/NCT04297384
NCT04297384
Completed
N/A

Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice

Roswell Park Cancer Institute1 site in 1 country174 target enrollmentFebruary 6, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anatomic Stage IV Breast Cancer AJCC v8
Sponsor
Roswell Park Cancer Institute
Enrollment
174
Locations
1
Primary Endpoint
Number of physician visits and diagnostic tests
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This trial studies the impact of the breast cancer pathways program on the patient experience, including decision making and quality of life. Measuring how the breast cancer pathways program affects decision making and quality of life in patients may help doctors improve cancer education.

Detailed Description

PRIMARY OBJECTIVES: I. Evaluate the impact of breast cancer pathways on patient experience, burden of decision making and quality of life in tertiary cancer center and community oncology practice. II. Identify modifiable factors that affect provider adoption of breast cancer pathways in tertiary cancer center and community oncology practice. OUTLINE: Participants are assigned to 1 of 2 groups. GROUP I: Participants receive standard chemotherapy educational materials. Participants also complete surveys over approximately 22 minutes at the time of first chemotherapy infusion, and approximately 8 weeks after first chemotherapy infusion. GROUP II: Participants receive personalized information about their cancer, treatment, and side effects. Participants also complete surveys over approximately 22 minutes at the time of first chemotherapy infusion, and approximately 8 weeks after first chemotherapy infusion.

Registry
clinicaltrials.gov
Start Date
February 6, 2019
End Date
August 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Treatment includes intravenous chemotherapy for breast cancer for primary disease as neoadjuvant or adjuvant therapy, or for recurrent and/or metastatic cancer
  • Can provide consent
  • Are able to comprehend written materials in English or Spanish
  • Will receive their chemotherapy at Roswell Park sites in Buffalo or Amherst, New York (NY), or Roswell Park Oncology primary care (PC) sites in Niagara Falls, Amherst, West Seneca, or Jamestown NY

Exclusion Criteria

  • Breast cancer patients receiving oral therapy alone
  • Patients who are not able to comprehend written materials in English or Spanish
  • Patients who will not receive chemotherapy at a Roswell Park site
  • Patients who are not able to comprehend written materials will not be included in this study, as the consent document will be administered in multiple infusion centers that cannot be all staffed daily with a research associate. The study instruments used are standardized tools that have been developed as best as possible with appropriate literacy levels
  • Patients enrolled in clinical trials for their breast chemotherapy will be excluded from this study because they will require alternative educational materials that are specific to the trial drugs being administered

Outcomes

Primary Outcomes

Number of physician visits and diagnostic tests

Time Frame: Up to 2 years

change in Patient quality of life

Time Frame: Baseline and 8 weeks

Assessed by surveys.

Change in Patient quality of decision

Time Frame: Baseline and 8 weeks

Assessed by surveys

Study Sites (1)

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