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

Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876238
• Other study ID #: CASE12112
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: November 25, 2015
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms
• Recurrent Breast Cancer
• Stage 4 Breast Cancer

Intervention

Other:
• T-PAT

• Surveys
Pre-test and posttest surveys and questionnaires

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Implementing the T-PAT Prognosis Discussion Intervention	Accuracy and completion rate of the planned intervention components will be observed.	8 months	Yes
Secondary	Patient Recorded Measures: Hope	Using the Snyder et al.'s State Hope Scale	8 months	No
Secondary	Patient Recorded Measures: Willingness to Tolerate Adverse States	Six-Item scale that measures motivation to endure burden associated with aggressive care. Higher scores indicate a greater willingness to tolerate adverse states.	8 months	No
Secondary	Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)	Assess patient physical function	8 months	No
Secondary	Patient Recorded Measures: Belief in Curability (BIC)	Assess patients perceptions about prognosis independent of what they recall being told by their doctor.	8 months	No
Secondary	Patient Recorded Measures: Illness Uncertainty	16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.	8 months	No
Secondary	Patient Recorded Measures: Treatment Goal Preference	Patients will be asked to report their preference for aggressive care.	8 months	No