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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T-PAT
Surveys
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Breast Cancer focused on measuring Breast Cancer, Patient-Doctor Communication, Supportive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T-PAT Intervention

Control: Standard Care

Arm Description

Prognosis discussion intervention with study team.

Usual care appointment

Outcomes

Primary Outcome Measures

Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
Accuracy and completion rate of the planned intervention components will be observed.

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2013
Last Updated
November 25, 2015
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01876238
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer, Stage 4 Breast Cancer, Recurrent Breast Cancer
Keywords
Breast Cancer, Patient-Doctor Communication, Supportive Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-PAT Intervention
Arm Type
Experimental
Arm Description
Prognosis discussion intervention with study team.
Arm Title
Control: Standard Care
Arm Type
Active Comparator
Arm Description
Usual care appointment
Intervention Type
Other
Intervention Name(s)
T-PAT
Intervention Type
Other
Intervention Name(s)
Surveys
Other Intervention Name(s)
State Hope Scale, Tolerate Adverse States Survey, Physical Functioning Measure (MOS-PF), Beleif in CUrability (BIC), Illness Uncertainty Survey, Treatment Goal Preference Questionnaire
Intervention Description
Pre-test and posttest surveys and questionnaires
Primary Outcome Measure Information:
Title
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
Description
Accuracy and completion rate of the planned intervention components will be observed.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Patient Recorded Measures: Hope
Description
Using the Snyder et al.'s State Hope Scale
Time Frame
8 months
Title
Patient Recorded Measures: Willingness to Tolerate Adverse States
Description
Six-Item scale that measures motivation to endure burden associated with aggressive care. Higher scores indicate a greater willingness to tolerate adverse states.
Time Frame
8 months
Title
Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)
Description
Assess patient physical function
Time Frame
8 months
Title
Patient Recorded Measures: Belief in Curability (BIC)
Description
Assess patients perceptions about prognosis independent of what they recall being told by their doctor.
Time Frame
8 months
Title
Patient Recorded Measures: Illness Uncertainty
Description
16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.
Time Frame
8 months
Title
Patient Recorded Measures: Treatment Goal Preference
Description
Patients will be asked to report their preference for aggressive care.
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Step, PhD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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