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NCT Number: NCT03198286

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

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.

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Key information

Conditions

Stage I Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases 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 Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive treatment summary and survivor care plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

A Pilot Study of the Clinical Implementation of the Carevive Survivor Care Planning System

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 26, 2017
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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