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Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals in Breast Cancer

Not Applicable
Completed
Conditions
Advanced Breast Cancer
Stage 4 Breast Cancer
Recurrent Breast Cancer
Interventions
Other: Surveys
Other: T-PAT
Registration Number
NCT01876238
Lead Sponsor
Case Comprehensive Cancer Center
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.

Detailed Description

The new communication practice (T-PAT) is a team approach for discussing prognosis and treatment goals. T-PAT is specifically designed to a) increase understanding of the prognosis and treatment goal, b) decrease illness uncertainty, and c) help the patient preserve hope for the future.This dedicated clinical visit features a structured discussion of prognosis, treatment goals and options, and end of life concerns. The planned team discussion will include information contributions for the treating medical oncologist, an oncology nurse and social worker who currently work together to provide breast cancer care.

Primary Objectives:

1. Assess the feasibility of implementing the T-PAT prognosis discussion intervention.

2. Compare the effects of T-PAT vs. usual care on pertinent patient reported outcomes including: a) understanding of the prognosis and treatment goal, b) illness uncertainty, and c) hope.

* First, a survey will be administered to patients in the waiting room before the next office visit. This should take 15-20 minutes.

* The second part involves participating in a scheduled appointment that will be audio-recorded and focus on sharing information about the patient's illness. Patients will be randomized to either participate in an appointment featuring new communication practices (T-PAT)or a regular care appointment.

* The third part involves a 20 minute survey, after the appointment, with a member of the study staff. This will take place over the telephone one or two days after the appointment.

* The fourth part is completion of a written reflection on the patients participation in the study, which will be returned in a pre-addressed, stamped envelope. Generally, this should take about 15 minutes.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
29
Inclusion Criteria
  • 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
Exclusion Criteria
  • Hospitalized
  • Unable to speak English
  • Unable to attend an office visit
  • ECOG performance score of >3

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control: Standard CareSurveysUsual care appointment
T-PAT InterventionT-PATPrognosis discussion intervention with study team.
T-PAT InterventionSurveysPrognosis discussion intervention with study team.
Primary Outcome Measures
NameTimeMethod
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention8 months

Accuracy and completion rate of the planned intervention components will be observed.

Secondary Outcome Measures
NameTimeMethod
Patient Recorded Measures: Willingness to Tolerate Adverse States8 months

Six-Item scale that measures motivation to endure burden associated with aggressive care. Higher scores indicate a greater willingness to tolerate adverse states.

Patient Recorded Measures: Belief in Curability (BIC)8 months

Assess patients perceptions about prognosis independent of what they recall being told by their doctor.

Patient Recorded Measures: Treatment Goal Preference8 months

Patients will be asked to report their preference for aggressive care.

Patient Recorded Measures: Hope8 months

Using the Snyder et al.'s State Hope Scale

Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)8 months

Assess patient physical function

Patient Recorded Measures: Illness Uncertainty8 months

16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

🇺🇸

Cleveland, Ohio, United States

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