Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT03514680

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2020-03-23

Brief 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.

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.

Conditions

Cancer; Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Period I

-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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Period II

• 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

Group Type: EXPERIMENTAL

CIPN Assessment and Management Algorithm

Intervention Type: BEHAVIORAL

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

Interventions

CIPN Assessment and Management Algorithm

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

-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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Robert Knoerl, PhD, RN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Knoerl, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34568984 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33676431 (View on PubMed)

Other Identifiers

18-049

Identifier Type: -

Identifier Source: org_study_id