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

Stage IIIA Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198286
• Other study ID #: 15P.046
• Status: Completed
• Phase: N/A
• First received: May 19, 2017
• Last updated: February 20, 2018
• Start date: August 1, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: February 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2016
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Ovarian Neoplasms
• Stage I Breast Cancer
• Stage I Cervical Cancer
• Stage I Ovarian Cancer
• Stage I Uterine Corpus Cancer
• Stage IA Breast Cancer
• Stage IA Cervical Cancer
• Stage IA Ovarian Cancer
• Stage IA Uterine Corpus Cancer
• Stage IB Breast Cancer
• Stage IB Cervical Cancer
• Stage IB Ovarian Cancer
• Stage IB Uterine Corpus Cancer
• Stage IC Ovarian Cancer
• Stage II Breast Cancer
• Stage II Cervical Cancer
• Stage II Ovarian Cancer
• Stage II Uterine Corpus Cancer
• Stage IIA Breast Cancer
• Stage IIA Cervical Cancer
• Stage IIA Ovarian Cancer
• Stage IIB Breast Cancer
• Stage IIB Cervical Cancer
• Stage IIB Ovarian Cancer
• Stage IIC Ovarian Cancer
• Stage III Breast Cancer
• Stage III Cervical Cancer
• Stage III Ovarian Cancer
• Stage III Uterine Corpus Cancer
• Stage IIIA Breast Cancer
• Stage IIIA Cervical Cancer
• Stage IIIA Ovarian Cancer
• Stage IIIA Uterine Corpus Cancer
• Stage IIIB Breast Cancer
• Stage IIIB Cervical Cancer
• Stage IIIB Ovarian Cancer
• Stage IIIB Uterine Corpus Cancer
• Stage IIIC Breast Cancer
• Stage IIIC Ovarian Cancer
• Stage IIIC Uterine Corpus Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Other:
• Informational Intervention
Receive treatment summary and survivor care plan

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Reading Hospital	Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital