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Survivorship Care Plans in a Community Oncology Practice

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ClinicalTrials.gov Identifier: NCT03028584
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This is a two part observational study evaluating the feasibility of implementing an EHR-based model within a community oncology practice.

Condition or disease Intervention/treatment
Breast Cancer Prostate Cancer Colorectal Cancer Behavioral: Survey

Detailed Description:

Part 1: The research team will use a sociotechnical work systems model, developed by researchers at the University of Wisconsin (UW) Systems Engineering Initiative for Patience Safety (SEIPS), to guide analysis of the work system barriers and facilitators to implementing an EHR-based care planning model in community oncology practice, collected from direct observations.

Part 2: The research team will measure reach/maintenance (percentage of survivors with EHR-based survivorship care plans (SCPs) over a 9-month time period) and impact (pre/post survey of patient satisfaction and perceived care coordination).


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clinicians

Observe up to N=10 clinicians. Observations will include:

  1. Oncology history and care plan development by clinicians including use of EHR technology to develop care plans and methods used to secure necessary information for care plan creation
  2. Provision and coordination of survivorship care occurring during care team meetings, discussions among clinicians, and survivor visits with clinicians, especially visits in which a care plan is provided to a survivor
  3. Clinician seeking survivorship related information or resources through use of technology or discussion with other clinicians
  4. Survivorship work or tasks performed by the clinician including adding, modifying or extracting information from the EHR and adding or modifying information in the care plan
Behavioral: Survey
Subjects (cancer patients and clinicians) will complete up to 2 surveys.

Clinicians and Patients

Surveys of N=30 breast cancer, colon cancer, and prostate cancer patients. Subjects will complete 1st survey electronically in-clinic. Subjects will either be e-mailed or mailed a survey at 4 weeks.

Survey of clinicians will be sent via e-mail.

Behavioral: Survey
Subjects (cancer patients and clinicians) will complete up to 2 surveys.




Primary Outcome Measures :
  1. EHR-based SCPs and care planning [ Time Frame: Up to 2 years ]
    Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.


Secondary Outcome Measures :
  1. Feasibility of providing EHR-based care planning, measured by SCP provision rates [ Time Frame: Up to 2 years ]
    Measured by SCP provision rates (percentage of survivors with EHR-based SCPs)

  2. Feasibility of providing EHR-based care planning, measured by the EHR [ Time Frame: Up to 2 years ]
    Measured by survivor access to SCPs, per the EHR

  3. Self-reported change in satisfaction, using survey [ Time Frame: Up to 2 years ]
    The impact of providing EHR-based care planning measured in change of satisfaction with perceived care coordination (assessed prior to and at 4 weeks after SCP provision)

  4. Impact of providing EHR-based care planning [ Time Frame: Up to 2 years ]
    Measured by reported SCP usability, usefulness, and content (assessed prior to and at 4 weeks after SCP provision)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Clinicians who provide care for breast, colon, or prostate patients.

Cancer patients/survivors of breast cancer (BrCa), prostate (PrCa), or colorectal (CRCa) cancer.

Criteria

Inclusion Criteria:

  • Clinicians: Provide cancer care to BrCa, CRCa or PrCa
  • Clinicians: Are a physician, advanced practice practitioner, nurse, or equivalent
  • Patients: Have a diagnosis of breast, colorectal, or prostate cancer for which and EHR-based SCP will be provided
  • Patients: Have been treated with curative intent (e.g. surgery, chemotherapy and/or radiation therapy) for a Stage 1-3 cancer diagnosis
  • Patients: Have received some part of active cancer treatment
  • Patients: Have complete active treatment (defined as surgery, chemotherapy, and/or radiation therapy). HER2-based and endocrine therapies may be ongoing and do NOT need to have been completed

Exclusion Criteria:

  • Unable to complete or unwilling to answer questions in English
  • Patients: Received all active cancer treatment elsewhere (e.g. "observation - only" patients)
  • Patients: Have metastatic cancer

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): NCT03028584


Contacts
Contact: Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu
Contact: Timothy Wassenaar, MD 262-696-5615 timothy.wassenaar@phci.org

Locations
United States, Wisconsin
UW Cancer Center at ProHealth Care Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Timothy Wassenaar, MD    262-696-5615    timothy.wassenaar@phci.org   
Principal Investigator: Mary Sesto, PT, PhD         
Principal Investigator: Amyé Tevaarwerk, MD         
Sub-Investigator: Timothy Wassenaar, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amyé Tevaarwerk, MD University of Wisconsin, Madison
Principal Investigator: Mary Sesto, PT, PhD University of Wisconsin, Madison

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03028584     History of Changes
Other Study ID Numbers: UW16029
P30CA014520 ( U.S. NIH Grant/Contract )
2016-0760 ( Other Identifier: Institutional Review Board )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by University of Wisconsin, Madison:
BrCa
PrCa
CRCa

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases