Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03198286|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Informational Intervention||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Pilot Study of the Clinical Implementation of the Carevive Survivor Care Planning System|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||August 1, 2015|
|Actual Study Completion Date :||October 31, 2016|
Experimental: Supportive care (survivor care plan, survey)
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
Receive treatment summary and survivor care plan
- Standard deviation will calculated to identify low-score items indicating problems that need to be addressed. [ Time Frame: 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 [ Time Frame: Up to 1 month ]Survivor reported outcomes will be evaluated.
- Patient reported activation as measured by the Patient Activation Survey [ Time Frame: Up to 1 month ]Survivor reported outcomes will be evaluated.
- Patient reported health behavior as measured by the Health Behavior Survey [ Time Frame: Up to 1 month ]Survivor reported outcomes will be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198286
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Reading, Pennsylvania, United States, 19602|
|Principal Investigator:||Andrea Barsevick, PhD||Sidney Kimmel Cancer Center at Thomas Jefferson University|