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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03198286
Other study ID # 15P.046
Secondary ID
Status Completed
Phase N/A
First received May 19, 2017
Last updated February 20, 2018
Start date August 1, 2015
Est. completion date October 31, 2016

Study information

Verified date February 2018
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 31, 2016
Est. primary completion date August 1, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Ovarian Neoplasms
  • 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
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms

Intervention

Other:
Informational Intervention
Receive treatment summary and survivor care plan

Locations

Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania
United States Reading Hospital Reading Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey Survivor reported outcomes will be evaluated. Up to 1 month
Primary Patient reported activation as measured by the Patient Activation Survey Survivor reported outcomes will be evaluated. Up to 1 month
Primary Patient reported health behavior as measured by the Health Behavior Survey Survivor reported outcomes will be evaluated. Up to 1 month
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