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

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01876238
Collaborator
(none)
29
1
2
25
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: T-PAT
  • Other: Surveys
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals With Patients Diagnosed With Advanced Breast Cancer
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Feasibility of Implementing the T-PAT Prognosis Discussion Intervention [8 months]

      Accuracy and completion rate of the planned intervention components will be observed.

    Secondary Outcome Measures

    1. Patient Recorded Measures: Hope [8 months]

      Using the Snyder et al.'s State Hope Scale

    2. Patient Recorded Measures: Willingness to Tolerate Adverse States [8 months]

      Six-Item scale that measures motivation to endure burden associated with aggressive care. Higher scores indicate a greater willingness to tolerate adverse states.

    3. Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF) [8 months]

      Assess patient physical function

    4. Patient Recorded Measures: Belief in Curability (BIC) [8 months]

      Assess patients perceptions about prognosis independent of what they recall being told by their doctor.

    5. Patient Recorded Measures: Illness Uncertainty [8 months]

      16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.

    6. Patient Recorded Measures: Treatment Goal Preference [8 months]

      Patients will be asked to report their preference for aggressive care.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • Case Comprehensive Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Case Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01876238
    Other Study ID Numbers:
    • CASE12112
    First Posted:
    Jun 12, 2013
    Last Update Posted:
    Nov 26, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Case Comprehensive Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 26, 2015