Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Number of physician visits and diagnostic tests
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Informational Intervention (Other)
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.
Intervention: Quality-of-Life Assessment (Other)
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.
Intervention: Survey Administration (Other)
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.
Intervention: Informational Intervention (Other)
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.
Intervention: Quality-of-Life Assessment (Other)
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.
Intervention: Survey Administration (Other)
Outcomes
Primary Outcomes
Number of physician visits and diagnostic tests
Time Frame: Up to 2 years
change in Patient quality of life
Time Frame: Baseline and 8 weeks
Assessed by surveys.
Change in Patient quality of decision
Time Frame: Baseline and 8 weeks
Assessed by surveys
Secondary Outcomes
No secondary outcomes reported