NCT03198286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

May 19, 2017

Last Update Submit

April 28, 2025

Conditions

Stage I Breast CancerStage I Cervical CancerStage I Ovarian CancerStage I Uterine Corpus CancerStage IA Breast CancerStage IA Cervical CancerStage IA Ovarian CancerStage IA Uterine Corpus CancerStage IB Breast CancerStage IB Cervical CancerStage IB Ovarian CancerStage IB Uterine Corpus CancerStage IC Ovarian CancerStage II Breast CancerStage II Cervical CancerStage II Ovarian CancerStage II Uterine Corpus CancerStage IIA Breast CancerStage IIA Cervical CancerStage IIA Ovarian CancerStage IIB Breast CancerStage IIB Cervical CancerStage IIB Ovarian CancerStage IIC Ovarian CancerStage III Breast CancerStage III Cervical CancerStage III Ovarian CancerStage III Uterine Corpus CancerStage IIIA Breast CancerStage IIIA Cervical CancerStage IIIA Ovarian CancerStage IIIA Uterine Corpus CancerStage IIIB Breast CancerStage IIIB Cervical CancerStage IIIB Ovarian CancerStage IIIB Uterine Corpus CancerStage IIIC Breast CancerStage IIIC Ovarian CancerStage IIIC Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (4)

  • 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

  • Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey

    Survivor reported outcomes will be evaluated.

    Up to 1 month

  • Patient reported activation as measured by the Patient Activation Survey

    Survivor reported outcomes will be evaluated.

    Up to 1 month

  • Patient reported health behavior as measured by the Health Behavior Survey

    Survivor reported outcomes will be evaluated.

    Up to 1 month

Study Arms (1)

Supportive care (survivor care plan, survey)

EXPERIMENTAL

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

Interventions

Informational InterventionOTHER

Receive treatment summary and survivor care plan

Supportive care (survivor care plan, survey)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Women who are pregnant
  • Vulnerable populations: cognitively impaired; prisoners; terminally ill; elderly and infirm; drug addicts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Reading Hospital

Reading, Pennsylvania, 19602, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Andrea Barsevick, PhD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

June 26, 2017

Study Start

August 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 31, 2016

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

US(2)