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

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00891969
First received: April 30, 2009
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Phase
Breast Cancer
 Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Process and Outcomes of Treatment Decision-Making Communication Between Oncologists and Newly Diagnosed Female Breast-Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • The association between patients' and physicians' participatory communication and psychosocial outcomes. [ Time Frame: Pre- and post-Initial treatment decision making visit ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed, early-stage, female, breast-cancer patients who are scheduled to see a participating surgical oncologist for an initial treatment decision making visit

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891969

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas J. Kearney, MD Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Thomas Joseph Kearney, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00891969     History of Changes
Other Study ID Numbers: CDR0000635781, P30CA072720, CINJ-040810
Study First Received: April 30, 2009
Last Updated: March 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013