跳至主要内容
临床试验/NCT01876238
NCT01876238已完成不适用

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

Case Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Hospitalized
  • Unable to speak English
  • Unable to attend an office visit
  • ECOG performance score of >3

结局指标

主要结局

Feasibility of Implementing the T-PAT Prognosis Discussion Intervention

时间窗: 8 months

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

次要结局

  • Patient Recorded Measures: Willingness to Tolerate Adverse States(8 months)
  • Patient Recorded Measures: Belief in Curability (BIC)(8 months)
  • Patient Recorded Measures: Treatment Goal Preference(8 months)
  • Patient Recorded Measures: Hope(8 months)
  • Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)(8 months)
  • Patient Recorded Measures: Illness Uncertainty(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Feasibility of a Team Approach for Discussing... | 临床试验