Clinical trial · Observational
Predicting the Impact of Treatment Toxicities on Health During Cancer ( PATTERN )
PATTERN: Predicting the Impact of Treatment Toxicities on Health During Cancer
NCT05790538CI-TRIAL-00098737completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Therapy Complications | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (survey, assessment, SmartSocks, monitor)
- description
- 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.
- interventionNames
- Procedure: Assessment of Therapy Complications
- Other: Electronic Health Record Review
- Other: Medical Device Usage and Evaluation
- Other: Survey Administration
Primary outcomes (5)
- measure
- Change in patient-reported neuropathy
- timeFrame
- Baseline up to 1 year after completion of chemotherapy (average of 16 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWinters-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