Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

Dana-Farber Cancer Institute

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy; Cancer

Treatments: Behavioral: CIPN Assessment and Management Algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03514680

18-049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients:

• 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,
• speaks/reads English,
• receives care from one of the clinicians enrolled in the study.

Exclusion Criteria for Patients:

• 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).

Inclusion Criteria for Clinicians:

-if they are a Medical Doctor, Physician Assistant, or Nurse Practitioner and provide care to oncology patients at one of the study sites

Inclusion Criteria for Healthy Controls:

-if they are an adult (18+) who does not have cancer or symptoms of peripheral nerve injury from any cause and speak/read English

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Period I

No Intervention group

Description:

-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 II

Experimental group

Description:

* 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

Treatment:

Behavioral: CIPN Assessment and Management Algorithm