Breast Cancer Pathways Program Impact on Patient Shared D... | NCT04297384

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

NCT04297384

Sponsor

Roswell Park Cancer Institute

Status

Completed

Last Update Posted

Apr 10, 2023Actual

Enrollment

174Actual

Phase

Not Applicable

Conditions

Anatomic Stage IV Breast Cancer AJCC v8
Breast Carcinoma
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Recurrent Breast Carcinoma

Interventions

Informational Intervention
Informational Intervention
Quality-of-Life Assessment
Survey Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2019-07900	Registry Identifier	CTRP (Clinical Trial Reporting Program)
I 60517	Other Identifier	Roswell Park Cancer Institute

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2019Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Aug 30, 2022Actual

First Submitted Date

Feb 27, 2020

First Submission Date that Met QC Criteria

Mar 3, 2020

First Posted Date

Mar 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2023

Last Update Posted Date

Apr 10, 2023Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

174Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I (standard educational materials, surveys)	Active Comparator	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.	Other: Informational Intervention Other: Quality-of-Life Assessment Other: Survey Administration
Group II (personalized information, surveys)	Experimental	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.	Other: Informational Intervention Other: Quality-of-Life Assessment Other: Survey Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Informational Intervention	Other	Receive standard chemotherapy educational materials	Group I (standard educational materials, surveys)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in Patient quality of life	Assessed by surveys.	Baseline and 8 weeks
Change in Patient quality of decision	Assessed by surveys	Baseline and 8 weeks
Number of physician visits and diagnostic tests		Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases