search
Back to results

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

Primary Purpose

Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Metastatic Breast Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational Intervention
Informational Intervention
Quality-of-Life Assessment
Survey Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (standard educational materials, surveys)

Group II (personalized information, surveys)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

change in Patient quality of life
Assessed by surveys.
Change in Patient quality of decision
Assessed by surveys
Number of physician visits and diagnostic tests

Secondary Outcome Measures

Full Information

First Posted
February 27, 2020
Last Updated
April 7, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT04297384
Brief Title
Breast Cancer Pathways Program Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Official Title
Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
Pfizer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8, Recurrent Breast Carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (standard educational materials, surveys)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group II (personalized information, surveys)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive standard chemotherapy educational materials
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive personalized information about cancer, treatment, and side effects
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete surveys
Primary Outcome Measure Information:
Title
change in Patient quality of life
Description
Assessed by surveys.
Time Frame
Baseline and 8 weeks
Title
Change in Patient quality of decision
Description
Assessed by surveys
Time Frame
Baseline and 8 weeks
Title
Number of physician visits and diagnostic tests
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Edge
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs