NCT03028584

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
Last Updated

November 18, 2019

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

November 10, 2016

Last Update Submit

November 14, 2019

Conditions

Keywords

BrCaPrCaCRCa

Outcome Measures

Primary Outcomes (1)

  • EHR-based SCPs and care planning

    Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.

    Up to 2 years

Secondary Outcomes (4)

  • Feasibility of providing EHR-based care planning, measured by SCP provision rates

    Up to 2 years

  • Feasibility of providing EHR-based care planning, measured by the EHR

    Up to 2 years

  • Self-reported change in satisfaction, using survey

    Up to 2 years

  • Impact of providing EHR-based care planning

    Up to 2 years

Study Arms (2)

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

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

Interventions

SurveyBEHAVIORAL

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

CliniciansClinicians and Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsColorectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Amyé Tevaarwerk, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
  • Mary Sesto, PT, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

January 23, 2017

Study Start

September 11, 2017

Primary Completion

February 28, 2018

Study Completion

March 23, 2018

Last Updated

November 18, 2019

Record last verified: 2018-10

Locations