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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297384
Recruitment Status : Active, not recruiting
First Posted : March 5, 2020
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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
Anatomic Stage IV Breast Cancer AJCC v8 Breast Carcinoma Metastatic Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Breast Carcinoma Other: Informational Intervention Other: Quality-of-Life Assessment Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 6, 2019
Estimated Primary Completion Date : February 6, 2023
Estimated Study Completion Date : February 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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 Name: Quality of Life Assessment

Other: Survey Administration
Complete surveys




Primary Outcome Measures :
  1. change in Patient quality of life [ Time Frame: Baseline and 8 weeks ]
    Assessed by surveys.

  2. Change in Patient quality of decision [ Time Frame: Baseline and 8 weeks ]
    Assessed by surveys

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297384


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Pfizer
Investigators
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Principal Investigator: Stephen B Edge Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04297384    
Other Study ID Numbers: I 60517
NCI-2019-07900 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 60517 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021

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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:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases