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

Study Overview
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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.

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

Conditions
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Stage IIC Ovarian Cancer, 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 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

Intervention / Treatment
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* Other: Informational Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (survivor care plan, survey)<br>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. | Other: Informational Intervention<br>* Receive treatment summary and survivor care plan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey | Survivor reported outcomes will be evaluated. | Up to 1 month | 
| Patient reported activation as measured by the Patient Activation Survey | Survivor reported outcomes will be evaluated. | Up to 1 month | 
| Patient reported health behavior as measured by the Health Behavior Survey | Survivor reported outcomes will be evaluated. | Up to 1 month |