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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Breast Carcinoma

Treatments: Other: Survey Administration; Other: Informational Intervention; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04297384

I 60517 (Other Identifier)

NCI-2019-07900 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Group I (standard educational materials, surveys)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Informational Intervention

Other: Informational Intervention

Group II (personalized information, surveys)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Informational Intervention

Other: Informational Intervention