Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors

February 20, 2018 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

A Pilot Study of the Clinical Implementation of the Carevive Survivor Care Planning System

This pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and resources.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIES:

I. To evaluate the feasibility of using the Carevive Survivor Care Planning System (SCPS) during the follow-up visit for breast oncology survivors treated in a university cancer center or a community medical center.

II. To evaluate survivors' perceptions of the usability of the Carevive technology.

III. To evaluate their perceptions of the acceptability (perception of benefit) of the treatment summary and survivor care plan.

SECONDARY OBJECTIVES:

I. Examine the psychometrics of surveys developed for this research. II. Compare participants' perceptions of the care received under the Carevive system with clinician documentation.

III. Compare clinician documentation of care received by this sample with documentation of care provided for historical controls at each site.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Reading, Pennsylvania, United States, 19602
        • Reading Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Prospective study: completed primary treatment for breast malignancies; receive survivorship care at Thomas Jefferson University (TJU) or Reading Health System (RHS)
  • Prospective study: individuals will have pathologically confirmed breast cancer (stages I-III)
  • Prospective study: Able to understand and read English
  • Prospective study: Physically capable of using a tablet computer (no severe visual, hearing, or hand motor deficits)
  • Retrospective chart review: Individuals will have pathologically confirmed breast cancer or gynecological (GYN) malignancies including uterine, ovarian, or cervical cancers, stages I-III; treated in the previous two years (2013-2014)

Exclusion Criteria:

  • Women who are pregnant
  • Vulnerable populations: cognitively impaired; prisoners; terminally ill; elderly and infirm; drug addicts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (survivor care plan, survey)
Patients receive a customized treatment summary and survivor care plan via the Carevive Survivor Care Planning System and review it during their follow-up visit. Patients also complete a survey on a tablet computer over 10-20 minutes before and after their follow-up visit.
Other: Informational Intervention
Receive treatment summary and survivor care plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard deviation will calculated to identify low-score items indicating problems that need to be addressed.
Time Frame: Up to 1 year
Feasibility information will be auto-generated by the Carevive system.
Up to 1 year
Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey
Time Frame: Up to 1 month
Survivor reported outcomes will be evaluated.
Up to 1 month
Patient reported activation as measured by the Patient Activation Survey
Time Frame: Up to 1 month
Survivor reported outcomes will be evaluated.
Up to 1 month
Patient reported health behavior as measured by the Health Behavior Survey
Time Frame: Up to 1 month
Survivor reported outcomes will be evaluated.
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Andrea Barsevick, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15P.046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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