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Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals With Patients Diagnosed With Advanced Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Advanced Breast Cancer, Stage 4 Breast Cancer, Recurrent Breast Cancer

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Trial Information

Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals With Patients Diagnosed With Advanced Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility of Implementing the T-PAT Prognosis Discussion Intervention

Outcome Description:

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

Outcome Time Frame:

8 months

Safety Issue:

Yes

Principal Investigator

Mary Step, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

CASE12112

NCT ID:

NCT01876238

Start Date:

May 2013

Completion Date:

October 2013

Related Keywords:

  • Advanced Breast Cancer
  • Stage 4 Breast Cancer
  • Recurrent Breast Cancer
  • Breast Cancer
  • Patient-Doctor Communication
  • Supportive Care
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065