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

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ClinicalTrials.gov Identifier: NCT03198286
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

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

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.


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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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Patient reported activation as measured by the Patient Activation Survey [ Time Frame: Up to 1 month ]
    Survivor reported outcomes will be evaluated.

  4. Patient reported health behavior as measured by the Health Behavior Survey [ Time Frame: Up to 1 month ]
    Survivor reported outcomes will be evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Reading Hospital
Reading, Pennsylvania, United States, 19602
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Andrea Barsevick, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03198286     History of Changes
Other Study ID Numbers: 15P.046
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Uterine Cervical Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Cervical Diseases
Uterine Diseases