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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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 Carcinoma

Intervention / Treatment
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* Other: Informational Intervention
* Other: Informational Intervention
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (standard educational materials, surveys)<br>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<br>* Receive standard chemotherapy educational materials<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Complete surveys<br>|
| Experimental: Group II (personalized information, surveys)<br>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<br>* Receive personalized information about cancer, treatment, and side effects<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Complete surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Patient quality of life | Assessed by surveys. | Baseline and 8 weeks | 
| Change in Patient quality of decision | Assessed by surveys | Baseline and 8 weeks | 
| Number of physician visits and diagnostic tests |  | Up to 2 years |