Breast CancerNCT03028584
Survivorship Care Plans in a Community Oncology Practice
An observational study of Breast Cancer and Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a two part observational study evaluating the feasibility of implementing an EHR-based model within a community oncology practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 23 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
About this study
Official title: Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice
This is a two part observational study evaluating the feasibility of implementing an EHR-based model within a community oncology practice.
Read the 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).
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- Being tested
- Survey
- Keywords
- BrCa, PrCa, CRCa
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Subjects (cancer patients and clinicians) will complete up to 2 surveys.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Survey | |
| 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. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
EHR-based SCPs and care planning
Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.
Measured: Up to 2 years
Secondary outcomes (4)
Feasibility of providing EHR-based care planning, measured by SCP provision rates
Measured by SCP provision rates (percentage of survivors with EHR-based SCPs)
Measured: Up to 2 years
Feasibility of providing EHR-based care planning, measured by the EHR
Measured by survivor access to SCPs, per the EHR
Measured: Up to 2 years
Self-reported change in satisfaction, using survey
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)
Measured: Up to 2 years
Impact of providing EHR-based care planning
Measured by reported SCP usability, usefulness, and content (assessed prior to and at 4 weeks after SCP provision)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start11 Sep 2017
- Primary completion28 Feb 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amyé Tevaarwerk, MD, Principal investigator, University of Wisconsin, MadisonMary Sesto, PT, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028584
- Sponsor's protocol ID
- UW16029
- Other IDs
- P30CA014520, 2016-0760, A534260, SMPH\MEDICINE\HEM-ONC
- Status last verified
- Oct 2018
- First submitted
- 10 Nov 2016
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice
- ClinicalTrials.gov ID
- NCT03028584
- Acronym / sponsor ID
- UW16029
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- Keywords
- BrCa, PrCa, CRCa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two part observational study evaluating the feasibility of implementing an EHR-based model within a community oncology practice.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinicians | – | Behavioral: SurveyObserve 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 |
| Clinicians and Patients | – | Behavioral: SurveySurveys 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySubjects (cancer patients and clinicians) will complete up to 2 surveys. | Behavioural | Clinicians, Clinicians and Patients |
Primary outcome
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.
4 secondary outcomes
Feasibility of providing EHR-based care planning, measured by SCP provision rates
Time frame: Up to 2 years
Feasibility of providing EHR-based care planning, measured by the EHR
Time frame: Up to 2 years
Self-reported change in satisfaction, using survey
Time frame: Up to 2 years
Impact of providing EHR-based care planning
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amyé Tevaarwerk, MD principal investigator
University of Wisconsin, Madison
Mary Sesto, PT, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EHR-based SCPs and care planning (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.