Predicting the Impact of Treatment Toxicities on Health During Cancer ( PATTERN )

Malignant Solid Neoplasm Clinical Trial

Official title: PATTERN: Predicting the Impact of Treatment Toxicities on Health During Cancer

Status Active, not recruiting

Clinical Trial Summary

This study investigates the effects of treatment from chemotherapy for cancer on symptoms, function, and falls during treatment and through the recovery phase of cancer care. The goal is to identify simple tests that can help medical providers predict which and when patients show increased risk for falls and functional decline and informing rehabilitation providers about which mobility deficits to target.

Clinical Trial Description

Aggressive treatments for cancer have improved survival, but often cause serious long-term adverse effects on daily life that last for many years. Chemotherapy-induced peripheral neuropathy (CIPN) is a persistent cancer treatment-related symptom that may negatively impact physical functioning, falls, and quality of life.

The persistence of CIPN symptoms and their relationship with life-threatening falls and disability point to a gap in oncology and follow-up care. A critical first step toward filling this gap is to characterize the natural trajectories of symptoms, functioning, and falls across the in-treatment and recovery phases of cancer care.

This study will prospectively enroll 200 adults with cancer that are scheduled to receive neurotoxic chemotherapy at the Portland campus of Oregon Health & Science University, 5 OHSU Knight Cancer Institute community hematology-oncology clinics, and OHSU research affiliate sites. Data collection occurs at patients' routine clinical appointments and at home via electronic surveys and passive monitoring devices. In the clinic, data collection occurs at 4-6 week intervals during treatment according to each patient's infusion schedule, and then approximately every 3 months for an additional year during routine follow-up care. Clinic-based assessments include tests of perceived sensation (tuning fork, monofilament, and biothesiometer), upper body strength (handgrip dynamometry), lower body strength (chair stand test), static balance (postural sway), and dynamic balance (Timed Up and Go test). Non-clinic-based data collection occurs weekly and assesses symptoms and falls via web-based surveys. At time points corresponding to clinic testing visits, participants are sent home with passive monitoring devices (instrumented socks and wrist-worn activity monitors) that measure physical activity and mobility.

PRIMARY OBJECTIVE:

I. To characterize trajectories of chemotherapy induced peripheral neuropathy (CIPN) symptoms and physical functioning (physical activity, mobility, self-report functioning and disability) and capture the variability in different patient trajectories across treatment and one year of recovery among persons receiving neurotoxic chemotherapy for cancer.

SECONDARY OBJECTIVE:

I. Determine whether or not patient characteristics alone can predict symptom and functioning trajectories or if adding clinical factors and simple tests of mobility significantly improves predictive capacity.

OUTLINE:

Patients complete surveys and clinic assessments at baseline, every 4-6 weeks during chemotherapy, and then every 3 months for 1 year after completion of chemotherapy. Clinic assessments include tests of neuropathy, upper and lower body strength, balance, and mobility. Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy. Patients' medical records are also reviewed. ;

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

• NCT number: NCT05790538
• Study type: Observational
• Source: OHSU Knight Cancer Institute
• Status: Active, not recruiting
• Start date: October 22, 2020
• Completion date: April 30, 2025