OncologyNCT05809557
EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity
A study testing Chemotherapy toxicity tool and Oncology Consultation in people with Oncology and Chemotherapeutic Toxicity, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oncology, Chemotherapeutic Toxicity, Metastatic Solid Tumor
- What is being tested?
- Chemotherapy toxicity tool and Oncology Consultation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 9 Jan 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer
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.
- Conditions
- Oncology, Chemotherapeutic Toxicity, Metastatic Solid Tumor
- Being tested
- Chemotherapy toxicity tool, Oncology Consultation
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy toxicity toolOther
Also called CARG
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.
Oncology ConsultationOther
Oncologists will consult new patient with a new diagnosis of cancer.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Not described Receives: Other: Oncology Consultation |
| Chemotherapy Toxicity Tool | Experimental | Not described Receives: Other: Chemotherapy toxicity tool; Other: Oncology Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned hospitalization rate
Measured at the patient level as a binary outcome (yes/no) based on date of initial visit with the oncologist.
Measured: Within 3 months of the Index Visit with the oncologist
Secondary outcomes (5)
Healthcare contact days
Measured at the patient level as a continuous outcome (number of days).
Measured: Within 3 and 6 months of the Index Visit with the oncologist
Chemotherapy use rate
Measured at the patient level as a binary outcome (yes/no) if patient ever received systemic cancer-directed treatment.
Measured: Within 3 months of the Index Visit with the oncologist
Chemotherapy modification rate
Measured at the patient level as a binary outcome (yes/no) if patient had dose, schedule, or number of chemotherapy changed.
Measured: Within 3 months of the Index Visit with the oncologist
Palliative Care Referral
Measured at the patient level as a binary outcome (yes/no) based on presence of a scheduled palliative care appointment
Measured: Within 6 months of the Index Visit with the oncologist
Chemotherapy toxicity tool use rate
Measured at the patient level as a binary outcome (yes/no) based on whether the oncologist used the tool for that patient.
Measured: Within 3 months of the Index Visit with the oncologist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start9 Jan 2023
- Primary completion9 Jun 2023
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Providers, who were selected based on having at least 20 new patients with metastatic solid tumors in a 6-month period in 2021, will be randomized in a 1:1 ratio, stratified by quartiles of patient volume.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809557
- Sponsor's protocol ID
- 2022LS125
- Other IDs
- STUDY00015357
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be housed as subset within the existing Center for Learning Health System Science/Center for Quality Outcomes, Discovery and Evaluation database covered by IRB 597 Protocol: STUDY00014481. Patient level data will not be shared with anyone outside the study team. Aggregated data will be shared with quality officials, hospital administrators, and more broadly disseminated in academic meetings and for publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer
- ClinicalTrials.gov ID
- NCT05809557
- Acronym / sponsor ID
- 2022LS125
- Conditions
- Oncology, Chemotherapeutic Toxicity, Metastatic Solid Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Providers, who were selected based on having at least 20 new patients with metastatic solid tumors in a 6-month period in 2021, will be randomized in a 1:1 ratio, stratified by quartiles of patient volume.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Other: Oncology Consultation |
| Chemotherapy Toxicity Tool | Experimental | Other: Chemotherapy toxicity tool, Other: Oncology Consultation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Chemotherapy toxicity toolAlso: CARGCARG 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 | Chemotherapy Toxicity Tool |
| Oncology ConsultationOncologists will consult new patient with a new diagnosis of cancer. | Other | Chemotherapy Toxicity Tool, Usual Care |
Primary outcome
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.
5 secondary outcomes
Healthcare contact days
Time frame: Within 3 and 6 months of the Index Visit with the oncologist
Chemotherapy use rate
Time frame: Within 3 months of the Index Visit with the oncologist
Chemotherapy modification rate
Time frame: Within 3 months of the Index Visit with the oncologist
Palliative Care Referral
Time frame: Within 6 months of the Index Visit with the oncologist
Chemotherapy toxicity tool use rate
Time frame: Within 3 months of the Index Visit with the oncologist
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 28 Feb 2024.
- Individual participant dataSharing planned: No. All data will be housed as subset within the existing Center for Learning Health System Science/Center for Quality Outcomes, Discovery and Evaluation database covered by IRB 597 Protocol: STUDY00014481. Patient level data will not be shared with anyone outside the study team. Aggregated data will be shared with quality officials, hospital administrators, and more broadly disseminated in academic meetings and for publication.
Related trials for Oncology
RecruitingPhase 1
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid Tumor
RecruitingPhase 1
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy toxicity tool and Oncology Consultation in people with Oncology and Chemotherapeutic Toxicity, run by Masonic Cancer Center, University of Minnesota 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 2 inclusion and 2 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 28 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Unplanned hospitalization rate (time frame: Within 3 months of the Index Visit with the oncologist). 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 28 Feb 2024.