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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer; Recurrent Breast Cancer; Stage 4 Breast Cancer
• Intervention / Treatment: Other: T-PAT; Other: Surveys

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: T-PAT Intervention; Prognosis discussion intervention with study team.	Other: T-PAT; Other: Surveys; Pre-test and posttest surveys and questionnaires; Other Names: State Hope Scale; Tolerate Adverse States Survey; Physical Functioning Measure (MOS-PF); Beleif in CUrability (BIC); Illness Uncertainty Survey; Treatment Goal Preference Questionnaire
ACTIVE_COMPARATOR: Control: Standard Care; Usual care appointment	Other: Surveys; Pre-test and posttest surveys and questionnaires; Other Names: State Hope Scale; Tolerate Adverse States Survey; Physical Functioning Measure (MOS-PF); Beleif in CUrability (BIC); Illness Uncertainty Survey; Treatment Goal Preference Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention	Accuracy and completion rate of the planned intervention components will be observed.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Recorded Measures: Hope	Using the Snyder et al.'s State Hope Scale	8 months
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
Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)	Assess patient physical function	8 months
Patient Recorded Measures: Belief in Curability (BIC)	Assess patients perceptions about prognosis independent of what they recall being told by their doctor.	8 months
Patient Recorded Measures: Illness Uncertainty	16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.	8 months
Patient Recorded Measures: Treatment Goal Preference	Patients will be asked to report their preference for aggressive care.	8 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Mary Step, PhD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (ESTIMATE): June 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer; Supportive Care; Patient-Doctor Communication
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE12112