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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The association between patients' and physicians' participatory communication and psychosocial outcomes.

Outcome Time Frame:

Pre- and post-Initial treatment decision making visit

Safety Issue:

No

Principal Investigator

Thomas J. Kearney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000635781

NCT ID:

NCT00891969

Start Date:

February 2009

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903