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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04297384
Collaborator
Pfizer (Industry)
174
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Informational Intervention
  • Other: Informational Intervention
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Actual Study Start Date :
Feb 6, 2019
Anticipated Primary Completion Date :
Feb 6, 2023
Anticipated Study Completion Date :
Feb 6, 2024

Arms and Interventions

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: Informational Intervention
Receive standard chemotherapy educational materials

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Complete surveys
    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: Informational Intervention
    Receive personalized information about cancer, treatment, and side effects

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Complete surveys

    Outcome Measures

    Primary Outcome Measures

    1. change in Patient quality of life [Baseline and 8 weeks]

      Assessed by surveys.

    2. Change in Patient quality of decision [Baseline and 8 weeks]

      Assessed by surveys

    3. Number of physician visits and diagnostic tests [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute
    • Pfizer

    Investigators

    • Principal Investigator: Stephen B Edge, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT04297384
    Other Study ID Numbers:
    • I 60517
    • NCI-2019-07900
    • I 60517
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    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
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 15, 2022