Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-01 @ 11:02 AM
Study NCT ID:
NCT00891969
Status:
TERMINATED
Last Update Posted:
2015-11-09
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Decision Making Between Oncologists and Women With Newly Diagnosed Breast Cancer and Their Healthy Companions
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
The Process and Outcomes of Treatment Decision-Making Communication Between Oncologists and Newly Diagnosed Female Breast-Cancer Patients
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
PURPOSE: This phase I trial is studying treatment decision making between oncologists and women with newly diagnosed breast cancer and their healthy companions.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA072720 | NIH | None | https://reporter.nih.gov/quic… | View |
| 0220080300 | None | None | View |