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TerminatedNCT00891969Updated Nov 9, 2015

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

An observational study in Breast Cancer, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-09.

Sponsored by Rutgers, The State University of New Jersey · Observational

Why this study was terminated
Slow accrual
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 77 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Eligibility 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
77 participants (actual)
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What researchers measure

Primary outcomes

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

    Time frame: Pre- and post-Initial treatment decision making visit

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Study locations

1 site
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08903, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00891969
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
Responsible party
Sponsor
First posted
May 1, 2009
Start date
Feb 2009
Primary completion
May 2010
Completion
Mar 2013
Last update
Nov 9, 2015

Study contacts

Thomas J. Kearney, MD
principal investigator · Rutgers Cancer Institute of New Jersey

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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