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NCT01627366 · ClinicalTrials.gov registry record · NA

Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors

A NA study of Breast Cancer, sponsored by Jonsson Comprehensive Cancer Center.

Completed
Registry status
NA
Development phase
500
Enrollment target
1
Study location

NCT01627366 is a NA study of Breast Cancer that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 500 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01627366, a NA study of Breast Cancer, has completed, sponsored by Jonsson Comprehensive Cancer Center.

COMPLETED
Registry status
NA
Development phase
500 participants
Enrollment target
1
Study location

Study Summary

Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer (BC) survivors. With so many individuals living for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to improve ongoing clinical and coordination of care, and to address the immediate post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844). This will be one of the first randomized controlled trials to test the efficacy of TSSPs. The investigators will recruit 500 low income, medically underserved women from two county public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 10-24 months after breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to test the efficacy of TSSPs. The investigators will randomize these women into one of two groups: 1) a control condition of usual medical care and 2) an experimental condition of the control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they can be clinically utilized. The investigators specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention: 1) discussion and implementation of recommended breast cancer survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with survivorship communication and care, 3) pertinent a

Conditions Studied

Interventions

  • OTHER Survivorship Care Plan

Study Locations (1)

California

  • UCLA - Los Angeles

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2012-08
Est. Completion 2015-07
Phase NA

Sponsor

Jonsson Comprehensive Cancer Center

321 total trials

What the Registry Record Tells You About NCT01627366

The ClinicalTrials.gov registry entry for NCT01627366 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Survivorship Care Plan is the first listed.

NCT01627366 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01627366 about?

NCT01627366 is a clinical study titled "Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors". Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer (BC) survivors. With so many individuals living for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the implementation of treatment summari...

What is the current status of trial NCT01627366?

This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2012-08. Estimated completion is 2015-07.

What conditions does trial NCT01627366 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT01627366?

The interventions under investigation include: Survivorship Care Plan (OTHER).

Who is sponsoring clinical trial NCT01627366?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01627366 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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