Clinical trial NCT01876238: Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals in Breast Cancer
Official title: Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals With Patients Diagnosed With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Breast Cancer
Stage 4 Breast Cancer
Recurrent Breast Cancer
Keywords: Breast Cancer
Patient-Doctor Communication
Supportive Care
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
timeFrame: 8 months
Secondary outcomes:
measure: Patient Recorded Measures: Hope
timeFrame: 8 months
measure: Patient Recorded Measures: Willingness to Tolerate Adverse States
timeFrame: 8 months
measure: Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)
timeFrame: 8 months
measure: Patient Recorded Measures: Belief in Curability (BIC)
timeFrame: 8 months
measure: Patient Recorded Measures: Illness Uncertainty
timeFrame: 8 months
measure: Patient Recorded Measures: Treatment Goal Preference
timeFrame: 8 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Mary Step, PhD
role: PRINCIPAL_INVESTIGATOR
References: