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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297384
• Other study ID #: I 60517
• Secondary ID: NCI-2019-07900I
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Metastatic Breast Carcinoma
• Prognostic Stage IV Breast Cancer AJCC v8
• Recurrent Breast Carcinoma

Intervention

Other:
• Informational Intervention
Receive standard chemotherapy educational materials
• Informational Intervention
Receive personalized information about cancer, treatment, and side effects
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Complete surveys

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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