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

NCT ID: NCT01876238

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-06-30

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:

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.

Conditions

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Advanced Breast Cancer Stage 4 Breast Cancer Recurrent Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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T-PAT Intervention

Prognosis discussion intervention with study team.

Group Type EXPERIMENTAL

T-PAT

Intervention Type OTHER

Surveys

Intervention Type OTHER

Pre-test and posttest surveys and questionnaires

Control: Standard Care

Usual care appointment

Group Type ACTIVE_COMPARATOR

Surveys

Intervention Type OTHER

Pre-test and posttest surveys and questionnaires

Interventions

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T-PAT

Intervention Type OTHER

Surveys

Pre-test and posttest surveys and questionnaires

Intervention Type OTHER

Other Intervention Names

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State Hope Scale Tolerate Adverse States Survey Physical Functioning Measure (MOS-PF) Beleif in CUrability (BIC) Illness Uncertainty Survey Treatment Goal Preference Questionnaire

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Step, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE12112

Identifier Type: -

Identifier Source: org_study_id