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

NCT03198286 — Not applicable, Completed, 40 participants, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

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

Registry	NCT03198286
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	40 (Actual)
Sponsor	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University (Other)
Conditions	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
Interventions	Informational Intervention (Other)
Dates	start 2015-08-01, primary completion 2015-08-01, completion 2016-10-31, first posted 2017-06-26, last updated 2025-04-29
Locations	2 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Supportive care (survivor care plan, survey)	Experimental	Other: Informational Intervention	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.

Informational Intervention (Other): Receive treatment summary and survivor care plan

+Outcome measures

Primary outcomes

Standard deviation will calculated to identify low-score items indicating problems that need to be addressed. [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 [Up to 1 month]: Survivor reported outcomes will be evaluated.
Patient reported activation as measured by the Patient Activation Survey [Up to 1 month]: Survivor reported outcomes will be evaluated.
Patient reported health behavior as measured by the Health Behavior Survey [Up to 1 month]: Survivor reported outcomes will be evaluated.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia, Pennsylvania	United States
Reading Hospital	Reading, Pennsylvania	United States

+Investigators

Andrea Barsevick, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

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