Trial Outcomes & Findings for Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer (NCT NCT03939481)

Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

Will be measured as an absolute increase of \>= 8 points over the baseline chemotherapy-induced peripheral neuropathy (CIPN)-20 sensory neuropathy subscale score. Will be collected before or at the 24-week assessment..

Patients experiencing a treatment change attributed to CIPN symptoms

Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)

Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.

Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead).

Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 \[no burden at all\] to 10 \[a great burden\]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 \[no burden at all\] to 10 \[a great burden\]), 2) to assess severity of side effects from cancer treatment (scale 0 \[no side effects\]) to 10 \[side effects extremely severe and unbearable\]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 \[side effects not severe at all\] to 10 \[side effects extremely severe and unbearable\]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 \[no burden at all\] to 10 \[a great burden\]).

Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI \> 24) and insufficiently active (LSI \< 23) categories.

Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE \[CTCAE Version 5.0\]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days".

The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range. Participants will only be graded for the event types listed above, so these will only be reported as an outcome measure, and will not appear in the adverse events section of this report.

Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.