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Completed

NCT Number: NCT03028584

Survivorship Care Plans 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

survey

Behavioral

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2017
Registry last updated
Nov 18, 2019

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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