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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04297384
Enrollment
174
Registered
2020-03-05
Start date
2019-02-06
Completion date
2022-08-30
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERInformational Intervention

Receive standard chemotherapy educational materials

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERSurvey Administration

Complete surveys

Sponsors

Pfizer
CollaboratorINDUSTRY
Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
change in Patient quality of lifeBaseline and 8 weeksAssessed by surveys.
Change in Patient quality of decisionBaseline and 8 weeksAssessed by surveys
Number of physician visits and diagnostic testsUp to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026