Breast Cancer Pathways Program Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
NCT ID: NCT04297384
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2019-02-06
2022-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Informational Intervention
Receive standard chemotherapy educational materials
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
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.
Informational Intervention
Receive personalized information about cancer, treatment, and side effects
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Interventions
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Informational Intervention
Receive standard chemotherapy educational materials
Informational Intervention
Receive personalized information about cancer, treatment, and side effects
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete surveys
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Stephen B Edge
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2019-07900
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 60517
Identifier Type: OTHER
Identifier Source: secondary_id
I 60517
Identifier Type: -
Identifier Source: org_study_id
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