Clinical trial NCT04297384: Breast Cancer Pathways Program Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Official title: Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Breast Carcinoma
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Recurrent Breast Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2020-03-05
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: change in Patient quality of life
timeFrame: Baseline and 8 weeks
measure: Change in Patient quality of decision
timeFrame: Baseline and 8 weeks
measure: Number of physician visits and diagnostic tests
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Stephen B Edge
role: PRINCIPAL_INVESTIGATOR
References: