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

NCT04297384 | Completed

• 2 other identifiers: I 60517NCI-2019-07900
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Informational Intervention OTHER

Receive standard chemotherapy educational materials

Group I (standard educational materials, surveys)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (standard educational materials, surveys); Group II (personalized information, surveys)

Survey Administration OTHER

Complete surveys

Group I (standard educational materials, surveys); Group II (personalized information, surveys)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Pfizer: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephen B Edge

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 5, 2020
• Study Start: February 6, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (1)