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

NCT ID: NCT03198286

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive treatment summary and survivor care plan

Interventions

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Informational Intervention

Receive treatment summary and survivor care plan

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Barsevick, PhD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

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Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Reading Hospital

Reading, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.kimmelcancercenter.org

Sidney Kimmel Cancer Center

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

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JT 7206

Identifier Type: OTHER

Identifier Source: secondary_id

15P.046

Identifier Type: -

Identifier Source: org_study_id

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