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NCT Number: NCT01876238

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

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.

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Key information

Conditions

Advanced Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Recurrent Breast Cancer Skin Diseases Skin and Connective Tissue Diseases Stage 4 Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-PAT

Other

Surveys

Other

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

Primary outcomes

  1. Feasibility of Implementing the T-PAT Prognosis Discussion Intervention

    Time frame: 8 months

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

Secondary outcomes

  1. Patient Recorded Measures: Hope

    Time frame: 8 months

    Using the Snyder et al.'s State Hope Scale

  2. Patient Recorded Measures: Willingness to Tolerate Adverse States

    Time frame: 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)

    Time frame: 8 months

    Assess patient physical function

  4. Patient Recorded Measures: Belief in Curability (BIC)

    Time frame: 8 months

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

  5. Patient Recorded Measures: Illness Uncertainty

    Time frame: 8 months

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

  6. Patient Recorded Measures: Treatment Goal Preference

    Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 12, 2013
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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