Trial Title:
Predicting the Impact of Treatment Toxicities on Health During Cancer ( PATTERN )
NCT ID:
NCT05790538
Condition:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Assessment of Therapy Complications
Description:
Complete clinic assessments
Arm group label:
Observational (survey, assessment, SmartSocks, monitor)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Medical records are reviewed
Arm group label:
Observational (survey, assessment, SmartSocks, monitor)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear SmartSocks
Arm group label:
Observational (survey, assessment, SmartSocks, monitor)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear activity monitor
Arm group label:
Observational (survey, assessment, SmartSocks, monitor)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete survey
Arm group label:
Observational (survey, assessment, SmartSocks, monitor)
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
40 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Start date:
October 22, 2020
Completion date:
April 30, 2025
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05790538
