- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028584
Survivorship Care Plans in a Community Oncology Practice
Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Waukesha, Wisconsin, United States, 53188
- UW Cancer Center at ProHealth Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clinicians
Observe up to N=10 clinicians. Observations will include:
|
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. |
Subjects (cancer patients and clinicians) will complete up to 2 surveys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Up to 2 years
|
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
|
Up to 2 years
|
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)
|
Up to 2 years
|
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)
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amyé Tevaarwerk, MD, University of Wisconsin, Madison
- Principal Investigator: Mary Sesto, PT, PhD, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW16029
- P30CA014520 (U.S. NIH Grant/Contract)
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- 2016-0760 (Other Identifier: Institutional Review Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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