Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals in Breast Cancer
1 other identifier
interventional
29
1 country
1
Brief Summary
This research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.The purpose of this study is to find out more about care planning during advanced breast cancer. The study will see if certain aspects of communication make a difference in how patients understand their illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 26, 2015
November 1, 2015
10 months
June 10, 2013
November 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
Accuracy and completion rate of the planned intervention components will be observed.
8 months
Secondary Outcomes (6)
Patient Recorded Measures: Hope
8 months
Patient Recorded Measures: Willingness to Tolerate Adverse States
8 months
Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)
8 months
Patient Recorded Measures: Belief in Curability (BIC)
8 months
Patient Recorded Measures: Illness Uncertainty
8 months
- +1 more secondary outcomes
Study Arms (2)
T-PAT Intervention
EXPERIMENTALPrognosis discussion intervention with study team.
Control: Standard Care
ACTIVE COMPARATORUsual care appointment
Interventions
Pre-test and posttest surveys and questionnaires
Eligibility Criteria
You may qualify if:
- Women newly or currently diagnosed with stage 4 or recurrent breast cancer
- Patients of Dr. Paula Silverman at Seidman Cancer Center
- Ambulatory
- Able to understand and participate in a discussion about their disease progression
You may not qualify if:
- Hospitalized
- Unable to speak English
- Unable to attend an office visit
- ECOG performance score of \>3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Step, PhD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
May 1, 2013
Primary Completion
March 1, 2014
Study Completion
June 1, 2015
Last Updated
November 26, 2015
Record last verified: 2015-11