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OpenTrials
Completed

NCT Number: NCT05809557

EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

This study will formally test the quality improvement intervention of an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity.

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Key information

Conditions

Oncology Chemotherapeutic Toxicity Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • New outpatient visits with a medical oncologist following a new diagnosis of cancer and no prior history of chemotherapy treatment.
  • aged > 65 will be included.

Exclusion criteria

  • Patients who opt out of clinical research will be excluded from analysis, but not the intervention (which will be applied to all patients). Specifically, as sometimes opt-in/opt out status is coded ambiguously in the data we will only analyze results of patients with clear opt in and no history of opt out.
  • Patients with no EHR data after initial oncologist appointment.

Treatment and study plan

Chemotherapy toxicity tool

Other

CARG is an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity. This intervention will make available a simple calculator which includes: Gender, Height and weight, Cancer Subtype, Hemoglobin, How is your hearing (with hearing aid, if needed)?, Number of falls in the past 6 months, Can you take your own medicines, Does your health limit you in walking one block., During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? and Glomerular filtration rate.

The CARG chemotoxicity calculator will be built into the patient navigator and its use will be assessed on a monthly basis and used to inform iteration.

Other names: CARG

Oncology Consultation

Other

Oncologists will consult new patient with a new diagnosis of cancer.

Primary outcomes

  1. Unplanned hospitalization rate

    Time frame: Within 3 months of the Index Visit with the oncologist

    Measured at the patient level as a binary outcome (yes/no) based on date of initial visit with the oncologist.

Secondary outcomes

  1. Healthcare contact days

    Time frame: Within 3 and 6 months of the Index Visit with the oncologist

    Measured at the patient level as a continuous outcome (number of days).

  2. Chemotherapy use rate

    Time frame: Within 3 months of the Index Visit with the oncologist

    Measured at the patient level as a binary outcome (yes/no) if patient ever received systemic cancer-directed treatment.

  3. Chemotherapy modification rate

    Time frame: Within 3 months of the Index Visit with the oncologist

    Measured at the patient level as a binary outcome (yes/no) if patient had dose, schedule, or number of chemotherapy changed.

  4. Palliative Care Referral

    Time frame: Within 6 months of the Index Visit with the oncologist

    Measured at the patient level as a binary outcome (yes/no) based on presence of a scheduled palliative care appointment

  5. Chemotherapy toxicity tool use rate

    Time frame: Within 3 months of the Index Visit with the oncologist

    Measured at the patient level as a binary outcome (yes/no) based on whether the oncologist used the tool for that patient.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 12, 2023
Registry last updated
Feb 28, 2024

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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