Treatment Decision Making Between Oncologists and Women With Newly Diagnosed Breast Cancer and Their Healthy Companions

Breast Cancer Clinical Trial

Official title:

The Process and Outcomes of Treatment Decision-Making Communication Between Oncologists and Newly Diagnosed Female Breast-Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00891969
• Other study ID #: 040810
• Secondary ID: P30CA07272002200
• Status: Terminated
• Phase: Phase 1
• First received: April 30, 2009
• Last updated: November 5, 2015
• Start date: February 2009
• Est. completion date: March 2013

Study information

• Verified date: November 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

RATIONALE: A study that looks at communication between patients and doctors may help oncologists improve patient satisfaction with their treatment plan.

PURPOSE: This phase I trial is studying treatment decision making between oncologists and women with newly diagnosed breast cancer and their healthy companions.

Description:

OBJECTIVES:

Primary

• To determine the association between women's and physicians' participatory communication behaviors (e.g., patients asking questions, physicians soliciting questions) on treatment decision-making process and health outcomes.

Secondary

• To capture the language used in the treatment-decision interactions.

• To assess the degree of variation in the language used among physicians and patients who are active participants and those who are less inclined to participate in the treatment decision-making interaction.

OUTLINE: Patients and their companions undergo consultation with the physician for treatment decision making. The treatment discussion is audio/videotaped for approximately 45 minutes.

Patients complete one short survey prior to physician consultation. After the treatment discussion, patients complete two short surveys, one immediately after the visit in the waiting room before leaving for the day, and the second one a week after the visit by a web-based survey or by mail.

PROJECTED ACCRUAL: A total of 300 women with breast cancer and 600 companions of these women will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: March 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Meets one of the following criteria:

• Woman with newly diagnosed early-stage breast cancer

• Caregiver or companion willing to participate in study

PATIENT CHARACTERISTICS:

• Speaks native English or has learned to speak English fluently

• Patient's companion = 18 years old (if applicable)

• Able to complete questionnaires without assistance

• Not pregnant

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between patients' and physicians' participatory communication and psychosocial outcomes.		Pre- and post-Initial treatment decision making visit	No