Treatment Decision Making Between Oncologists and Women With Newly Diagnosed Breast Cancer and Their Healthy Companions
NCT ID: NCT00891969
Last Updated: 2015-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
77 participants
OBSERVATIONAL
2009-02-28
2013-03-31
Brief Summary
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PURPOSE: This phase I trial is studying treatment decision making between oncologists and women with newly diagnosed breast cancer and their healthy companions.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers Cancer Institute of New Jersey
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Thomas J. Kearney, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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0220080300
Identifier Type: -
Identifier Source: secondary_id
040810
Identifier Type: -
Identifier Source: org_study_id
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