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Clinical Trials/NCT03198286
NCT03198286
Completed
N/A

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

Sidney Kimmel Cancer Center at Thomas Jefferson University2 sites in 1 country40 target enrollmentAugust 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stage I Breast Cancer
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Enrollment
40
Locations
2
Primary Endpoint
Patient reported activation as measured by the Patient Activation Survey
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2015
End Date
October 31, 2016
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient reported activation as measured by the Patient Activation Survey

Time Frame: Up to 1 month

Survivor reported outcomes will be evaluated.

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.

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.

Patient reported health behavior as measured by the Health Behavior Survey

Time Frame: Up to 1 month

Survivor reported outcomes will be evaluated.

Study Sites (2)

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