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

Primary Purpose

Stage I Breast Cancer, Stage I Cervical Cancer, Stage I Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational Intervention
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stage I Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Reading Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (survivor care plan, survey)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey
Survivor reported outcomes will be evaluated.
Patient reported activation as measured by the Patient Activation Survey
Survivor reported outcomes will be evaluated.
Patient reported health behavior as measured by the Health Behavior Survey
Survivor reported outcomes will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2017
Last Updated
February 20, 2018
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03198286
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
August 1, 2015 (Actual)
Study Completion Date
October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (survivor care plan, survey)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive treatment summary and survivor care plan
Primary Outcome Measure Information:
Title
Standard deviation will calculated to identify low-score items indicating problems that need to be addressed.
Description
Feasibility information will be auto-generated by the Carevive system.
Time Frame
Up to 1 year
Title
Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey
Description
Survivor reported outcomes will be evaluated.
Time Frame
Up to 1 month
Title
Patient reported activation as measured by the Patient Activation Survey
Description
Survivor reported outcomes will be evaluated.
Time Frame
Up to 1 month
Title
Patient reported health behavior as measured by the Health Behavior Survey
Description
Survivor reported outcomes will be evaluated.
Time Frame
Up to 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Barsevick, PhD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Reading Hospital
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19602
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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