Clinical trial NCT05790538: Predicting the Impact of Treatment Toxicities on Health During Cancer ( PATTERN )
Official title: PATTERN: Predicting the Impact of Treatment Toxicities on Health During Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2023-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-III cancer without neurologic involvement who are scheduled to receive neurotoxic chemotherapy at Oregon Health \& Science University (OHSU) Knight Cancer Institute

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age 40-85 years old on date of enrollment.
* Diagnosed with stage I-III cancer, or stage IV cancer considered curable, other than cancers or metastases in the brain or spinal cord.
* Scheduled to receive any neurotoxic chemotherapy including taxane derivative, platinum complex, and/or vinca alkyloids

Exclusion Criteria:

* Previously received neurotoxic chemotherapy
* Cognitive difficulties that preclude answering the survey questions, participating in the performance tests, or giving informed consent
* A medical condition, movement or neurological disorder, or medication use that contraindicates participation in mobility testing and/or that confounds the ability to detect treatment-related changes in balance and mobility. Specific medical conditions include, but are not limited to, severe dystrophy, severe spasticity, epilepsy, seizures, Alzheimer's and dementia, while physical conditions include a severe balance disorder (i.e., later-stage Parkinson's, stroke), inability to ambulate (use of an assistive device permitted), inability to stand for 3 minutes, or severe hearing or vision problem

Primary outcomes:
measure: Change in patient-reported neuropathy
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in patient-reported neuropathy
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in perceived disability
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in daily functional mobility
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in daily physical activity
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Secondary outcomes:
measure: Falls
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in quality of life
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in patient-reported symptoms
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in objective loss of perceived sensation
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in objective loss of perceived sensation
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in upper extremity strength
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in static balance
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in functional mobility
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in objective functional strength
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
measure: Change in skeletal muscle index
timeFrame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone
role: PRINCIPAL_INVESTIGATOR
References: