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

Study Overview
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Brief Summary
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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
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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: Assess the feasibility of implementing the T-PAT prognosis discussion intervention. 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.

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

Conditions
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Advanced Breast Cancer, Stage 4 Breast Cancer, Recurrent Breast Cancer

Intervention / Treatment
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* Other: T-PAT
* Other: Surveys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-PAT Intervention<br>Prognosis discussion intervention with study team. | Other: T-PAT<br> <br> Other: Surveys<br>* Pre-test and posttest surveys and questionnaires<br>* Other names: Treatment Goal Preference Questionnaire;|
| Active Comparator: Control: Standard Care<br>Usual care appointment | Other: Surveys<br>* Pre-test and posttest surveys and questionnaires<br>* Other names: Treatment Goal Preference Questionnaire;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Patient-Doctor Communication, Supportive Care