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

NCT05790538 | Completed

• 3 other identifiers: STUDY00021969NCI-2021-05944R01CA248059
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• Change in patient-reported neuropathy

  Measured using the neuropathy subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTX-13) questionnaire, which assesses the presence, severity and impact of neuropathy symptoms in patients receiving neurotoxic chemotherapy. The scale ranges from 0-52, with lower scores indicating worse quality of life due to neuropathy.

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in patient-reported neuropathy

  Measured using the Patient-Reported Outcomes version of the Common Toxicity Criteria and Adverse Events version 1.0 (PRO-CTCAE™) reporting tool. Two items from the PRO-CTCAE™ ask if the patient experienced numbness or tingling in the hands or feet in the last 7 days using a 5-pt scale (0=none to 4=very severe) and how much the symptom interfered with their daily life using a 5-pt scale (0=not at all to 4=very much).

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in perceived disability

  Measured using the disability component of the Late-Life Function and Disability Instrument (LLFDI) which assesses disability in terms of frequency and limitation in performing 16 life tasks. Scores range from 0 to 100, with higher scores indicating less disability.

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in daily functional mobility

  Measured using instrumented socks (APDM.com) with inertial sensors embedded into neoprene ankle wraps. Patients wear the instrumented socks during waking hours over 7-day periods that correspond to each in-clinic assessment.

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in daily physical activity

  Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/d). Patients wear the devices over 7-day periods that correspond to each in-clinic assessment.

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

Secondary Outcomes (10)

• Falls

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in quality of life

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in patient-reported symptoms

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in objective loss of perceived sensation

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

• Change in objective loss of perceived sensation

  Baseline up to 1 year after completion of chemotherapy (average of 16 months)

Study Arms (1)

Observational (survey, assessment, SmartSocks, monitor)

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. After main study, patients may optionally complete surveys every 6 months for up to 5 years on study.

Procedure: Assessment of Therapy Complications; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Survey Administration

Interventions

Assessment of Therapy Complications PROCEDURE

Complete clinic assessments

Observational (survey, assessment, SmartSocks, monitor)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (survey, assessment, SmartSocks, monitor)

Medical Device Usage and Evaluation OTHER

Wear SmartSocks

Observational (survey, assessment, SmartSocks, monitor)

Survey Administration OTHER

Complete survey

Observational (survey, assessment, SmartSocks, monitor)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Winters-Stone KM, Krasnow SM, Horak FB, Mancini M, Cameron MH, Dieckmann NF, Stoyles SA, Roeland EJ. Identifying trajectories and predictors of chemotherapy-induced peripheral neuropathy symptoms, physical functioning, and falls across treatment and recovery in adults treated with neurotoxic chemotherapy: the PATTERN observational study protocol (NCT05790538). BMC Cancer. 2023 Nov 10;23(1):1087. doi: 10.1186/s12885-023-11546-2.

  PMID: 37946117 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kerri Winters-Stone

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 30, 2023
• Study Start: October 22, 2020
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)