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

Not Applicable

Completed

• Conditions: Stage I Uterine Corpus Cancer; Stage IA Cervical Cancer; Stage II Uterine Corpus Cancer; Stage III Uterine Corpus Cancer; Stage IIIA Cervical Cancer; Stage IIIB Ovarian Cancer; Stage I Breast Cancer; Stage I Cervical Cancer; Stage I Ovarian Cancer; Stage IA Ovarian Cancer
• Interventions: Other: Informational Intervention

• Registration Number: NCT03198286
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2015-08-01
• Study Completion: 2016-10-31
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (survivor care plan, survey)	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Reading Hospital; 🇺🇸 Reading, Pennsylvania, United States