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

NCT ID: NCT05790538

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2025-06-06

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Assessment of Therapy Complications

Intervention Type: PROCEDURE

Complete clinic assessments

Electronic Health Record Review

Intervention Type: OTHER

Medical records are reviewed

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear SmartSocks

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear activity monitor

Survey Administration

Intervention Type: OTHER

Complete survey

Interventions

Assessment of Therapy Complications

Complete clinic assessments

Intervention Type: PROCEDURE

Electronic Health Record Review

Medical records are reviewed

Intervention Type: OTHER

Medical Device Usage and Evaluation

Wear SmartSocks

Intervention Type: OTHER

Medical Device Usage and Evaluation

Wear activity monitor

Intervention Type: OTHER

Survey Administration

Complete survey

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kerri Winters

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerri Winters-Stone

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37946117 (View on PubMed)

Other Identifiers

NCI-2021-05944

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00021969

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA248059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021969

Identifier Type: -

Identifier Source: org_study_id