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

NCT04297384

Last updated date
Study Location
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8, Recurrent Breast Carcinoma
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8, Recurrent Breast CarcinomaBreast Cancer Pathways Program Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
NCT04297384
  1. Buffalo, New York
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Breast Cancer Pathways Program Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Official Title  ICMJE Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Recurrent Breast Carcinoma
Intervention  ICMJE
  • Other: Informational Intervention
    Receive standard chemotherapy educational materials
  • Other: Informational Intervention
    Receive personalized information about cancer, treatment, and side effects
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Survey Administration
    Complete surveys
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Informational Intervention
    • Other: Quality-of-Life Assessment
    • Other: Survey Administration
  • 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.
    Interventions:
    • Other: Informational Intervention
    • Other: Quality-of-Life Assessment
    • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 6, 2024
Estimated Primary Completion Date February 6, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04297384
Other Study ID Numbers  ICMJE I 60517
NCI-2019-07900 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 60517 ( Other Identifier: Roswell Park Cancer Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Stephen B EdgeRoswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP