Clinical trial NCT03198286: Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors
Official title: A Pilot Study of the Clinical Implementation of the Carevive Survivor Care Planning System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Standard deviation will calculated to identify low-score items indicating problems that need to be addressed.
timeFrame: Up to 1 year
measure: Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey
timeFrame: Up to 1 month
measure: Patient reported activation as measured by the Patient Activation Survey
timeFrame: Up to 1 month
measure: Patient reported health behavior as measured by the Health Behavior Survey
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Andrea Barsevick, PhD
role: PRINCIPAL_INVESTIGATOR
References: