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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Anatomic Stage IV Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Breast Carcinoma; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Informational Intervention; Other: Informational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (standard educational materials, surveys); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Survey Administration; Complete surveys; Other: Informational Intervention; Receive standard chemotherapy educational materials; Other: Informational Intervention; Receive personalized information about cancer, treatment, and side effects
Experimental: Group II (personalized information, surveys); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Survey Administration; Complete surveys; Other: Informational Intervention; Receive standard chemotherapy educational materials; Other: Informational Intervention; Receive personalized information about cancer, treatment, and side effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Patient quality of life	Assessed by surveys.	Baseline and 8 weeks
Change in Patient quality of decision	Assessed by surveys	Baseline and 8 weeks
Number of physician visits and diagnostic tests		Up to 2 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: Pfizer
• Investigators: Principal Investigator: Stephen B Edge, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: I 60517 (Other Identifier: Roswell Park Cancer Institute); NCI-2019-07900 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No