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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2022-08-30

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.

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive standard chemotherapy educational materials

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive personalized information about cancer, treatment, and side effects

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Informational Intervention

Receive standard chemotherapy educational materials

Intervention Type OTHER

Informational Intervention

Receive personalized information about cancer, treatment, and side effects

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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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