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CancerNCT03514680

Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

A study testing CIPN Assessment and Management Algorithm in people with Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is evaluating how well a decision support tool works to improve clinicians' use of recommended chemotherapy-induced peripheral neuropathy (CIPN) assessment and management strategies in participants receiving chemotherapy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
CIPN Assessment and Management Algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteUnited States
Study dates
4 Jun 2018to 23 Mar 2020
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • over 18 years of age,
  • completed one infusion of neurotoxic chemotherapy for the treatment of cancer
  • has at least three more planned clinic visits associated with neurotoxic chemotherapy receipt after the day of consent
  • ambulatory,
  • signed informed consent,
  • willingness to participate in all study activities,
Show all 10Show fewer
  • speaks/reads English,
  • receives care from one of the clinicians enrolled in the study.
  • -if they are a Medical Doctor, Physician Assistant, or Nurse Practitioner and provide care to oncology patients at one of the study sites
  • -if they are an adult (18+) who does not have cancer or symptoms of peripheral nerve injury from any cause and speak/read English

Who cannot join

  • prognosis of ≤ two months or
  • documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, central nervous system malignancy, vitamin B deficiency, hereditary, nerve compression injury).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations

This research study is evaluating how well a decision support tool works to improve clinicians' use of recommended chemotherapy-induced peripheral neuropathy (CIPN) assessment and management strategies in participants receiving chemotherapy.

Read the detailed description

This research study will test a new clinician decision support tool for the assessment and management of CIPN. The algorithm is designed to help clinicians make decisions about which strategies to use for the assessment and/or management of CIPN. The investigators need to recruit participants receiving chemotherapy that is known to cause CIPN to determine how well the algorithm works to increase clinicians' use of recommended CIPN assessment and management strategies.

Being tested
CIPN Assessment and Management Algorithm
Keywords
Cancer Care, Chemotherapy-induced peripheral neuropathy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIPN Assessment and Management AlgorithmBehavioural

    The revised algorithm incorporates evidence-based CIPN assessment and management strategies and standardized CIPN/pain patient-reported outcomes measures. In terms of processes, trained study staff will administer the screening questionnaires (e.g., PRO-CTCAE, 0 - 10 numerical rating scale of worst CIPN pain intensity) to consented patients before their clinician visit (e.g., in the waiting room). Following patient completion of the screening questionnaires, study staff will provide the clinicians with a color-coded summary of the patients' responses to the screening questionnaires and the CIPN assessment and management algorithm. Clinicians may then use the algorithm at their discretion to guide the assessment and management of their patients' CIPN symptoms

Study groups in NCT03514680
Study groupRoleWhat they receive
Period INo intervention-Consented patients will complete electronic versions of the PRO-CTCAE CIPN severity and interference items, 0 - 10 worst CIPN pain numerical rating scale, and QLQ-CIPN20 via tablet prior to their clinician visit at the outpatient oncology center at three consecutive clinic visits: baseline, visit 2, visit 3.
Period IIExperimental* Consented patients will complete the same battery of assessments from the usual care period at the baseline, visit 2, and visit 3 time points. * Following patient completion of the screening questionnaires, study staff will provide the clinicians with a color-coded summary of the patients' responses to the screening questionnaires and the CIPN assessment and management algorithm
Receives: Behavioral: CIPN Assessment and Management Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician Medical Record Abstraction Form

    Frequency of clinician CIPN assessment and management documentation for each period.

    Measured: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.

Secondary outcomes (5)

  1. European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20): Sensory and Motor Subscales

    Change in QLQ-CIPN20 scores between periods. Subscale total scores are scored from 0 - 100, higher scores represent worse neuropathy symptoms.

    Measured: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.

  2. Patient-Reported Outcomes National Cancer Institute Common Terminology Criteria for Adverse Events CIPN Severity and Interference Items

    Reliability and validity testing of measure. The severity and interference items are scored from 0 - 4, with higher scores representing worse neuropathy.

    Measured: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.

  3. 0 - 10 Worst CIPN Numerical Rating Scale

    Change in 0 - 10 Worst CIPN Numerical Rating Scale score between periods. Scored from 0 - 10, higher scores represent worse pain.

    Measured: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.

  4. Adapted Acceptability E - Scale

    Mean score will be calculated to determine clinician-related acceptability and satisfaction with intervention use. Each item is scored from 1 - 5, with higher scores representing greater acceptability and satisfaction.

    Measured: From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.

  5. Feasibility of Algorithm Implementation

    Mean score to examine feasibility of intervention feasibility. Each item is scored from 1 - 5, with higher scores representing greater feasibility. Will be completed by clinicians only.

    Measured: From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2018
  2. Study start4 Jun 2018
  3. Primary completion30 Dec 2019
  4. Study completion23 Mar 2020

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study expect to enroll 162 patients, 60 clinicians, and 30 healthy controls for a total of 252. 81 patients will be recruited in Period 1 (usual care) and a separate 81 will be recruited in Period 2 (algorithm use). The 60 clinicians will be recruited and will participate in Periods I and II. We will use purposive sampling to recruit 30 health controls to match the age and demographic characteristics of the recruited patients. The healthy controls will receive no intervention.
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03514680
Sponsor's protocol ID
18-049
Status last verified
Mar 2022
First submitted
21 Apr 2018
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Knoerl R, Mazzola E, Mitchell SA, Hong F, Salehi E, McCleary N, Ligibel JA, Reyes K, Berry DL. Measurement properties of brief neuropathy screening items in cancer patients receiving taxanes, platinums, or proteasome inhibitors. J Patient Rep Outcomes. 2021 Sep 26;5(1):101. doi: 10.1186/s41687-021-00377-z.

    PubMed 34568984

  • Knoerl R, Mazzola E, Hong F, Salehi E, McCleary N, Ligibel J, Reyes K, Berry DL. Exploring the impact of a decision support algorithm to improve clinicians' chemotherapy-induced peripheral neuropathy assessment and management practices: a two-phase, longitudinal study. BMC Cancer. 2021 Mar 6;21(1):236. doi: 10.1186/s12885-021-07965-8.

    PubMed 33676431

Questions about this trial

What is this clinical trial studying?

A study testing CIPN Assessment and Management Algorithm in people with Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Dana-Farber Cancer Institute 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 10 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 16 Mar 2022. 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?

Clinician Medical Record Abstraction Form (time frame: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514680, which also lists 2 linked publications.

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 16 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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