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Effets du traitement sur le développement de la neuropathie périphérique induite par la chimiothérapie chez les patients atteints de cancer

10 septembre 2026 mis à jour par: SWOG Cancer Research Network

Une étude de cohorte observationnelle prospective pour développer un modèle prédictif de neuropathie périphérique induite par les taxanes chez les patients cancéreux

This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVES:

I. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens.

SECONDARY OBJECTIVES:

I. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population.

II. To assess the incidence of CIPN within one year in this patient population. III. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population.

OTHER OBJECTIVES:

I. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.

OUTLINE:

Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.

Type d'étude

Observationnel

Inscription (Réel)

1336

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chili
      • Independence, Chili, 8380455
        • Instituto Nacional del Cancer
  • Colombie
      • Bogotá, Colombie, 99999
        • Instituto Nacional De Cancerologia
  • Mexique
    • Tlalpan
      • Mexico City, Tlalpan, Mexique, 14080
        • Instituto Nacional De Cancerologia de Mexico
  • États-Unis
    • California
      • Antioch, California, États-Unis, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Dublin, California, États-Unis, 94568
        • Kaiser Permanente Dublin
      • Fremont, California, États-Unis, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, États-Unis, 93720
        • Kaiser Permanente-Fresno
      • Oakland, California, États-Unis, 94611
        • Kaiser Permanente-Oakland
      • Palm Springs, California, États-Unis, 92262
        • Desert Regional Medical Center
      • San Francisco, California, États-Unis, 94115
        • Kaiser Permanente-San Francisco
      • San Jose, California, États-Unis, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, États-Unis, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, États-Unis, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, États-Unis, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, États-Unis, 95403
        • Kaiser Permanente-Santa Rosa
      • Vacaville, California, États-Unis, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, États-Unis, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, États-Unis, 94596
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Rocky Mountain Regional VA Medical Center
    • Delaware
      • Dover, Delaware, États-Unis, 19901
        • Bayhealth Hospital Kent Campus
      • Milford, Delaware, États-Unis, 19963
        • Bayhealth Hospital Sussex Campus
    • Florida
      • Fort Myers, Florida, États-Unis, 33905
        • Regional Cancer Center-Lee Memorial Health System
      • Fort Myers, Florida, États-Unis, 33905
        • Florida Gynecologic Oncology
      • Pensacola, Florida, États-Unis, 32504
        • Sacred Heart Hospital
    • Georgia
      • Savannah, Georgia, États-Unis, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, États-Unis, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, États-Unis, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, États-Unis, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, États-Unis, 96819
        • Kaiser Permanente Moanalua Medical Center
      • Lihue, Hawaii, États-Unis, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, États-Unis, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, États-Unis, 96701
        • Hawaii Cancer Care - Savio
    • Illinois
      • Centralia, Illinois, États-Unis, 62801
        • Centralia Oncology Clinic
      • Danville, Illinois, États-Unis, 61832
        • Carle on Vermilion
      • Decatur, Illinois, États-Unis, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, États-Unis, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, États-Unis, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, États-Unis, 62401
        • Carle Physician Group-Effingham
      • Evergreen Park, Illinois, États-Unis, 60805
        • Little Company of Mary Hospital
      • Hines, Illinois, États-Unis, 60141
        • Edward Hines Jr VA Hospital
      • Mattoon, Illinois, États-Unis, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Moline, Illinois, États-Unis, 61265
        • Trinity Medical Center
      • O'Fallon, Illinois, États-Unis, 62269
        • Cancer Care Center of O'Fallon
      • Urbana, Illinois, États-Unis, 61801
        • Carle Cancer Center
      • Urbana, Illinois, États-Unis, 61801
        • The Carle Foundation Hospital
    • Iowa
      • Ames, Iowa, États-Unis, 50010
        • McFarland Clinic PC - Ames
      • Cedar Rapids, Iowa, États-Unis, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, États-Unis, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, États-Unis, 52402
        • Physicians' Clinic of Iowa PC
      • Clive, Iowa, États-Unis, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, États-Unis, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Creston, Iowa, États-Unis, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, États-Unis, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, États-Unis, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, États-Unis, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, États-Unis, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, États-Unis, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • West Des Moines, Iowa, États-Unis, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Hays, Kansas, États-Unis, 67601
        • HaysMed University of Kansas Health System
      • Lawrence, Kansas, États-Unis, 66044
        • Lawrence Memorial Hospital
      • Olathe, Kansas, États-Unis, 66061
        • Olathe Health Cancer Center
      • Salina, Kansas, États-Unis, 67401
        • Salina Regional Health Center
      • Topeka, Kansas, États-Unis, 66606
        • University of Kansas Health System Saint Francis Campus
      • Wichita, Kansas, États-Unis, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, États-Unis, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, États-Unis, 67208
        • Associates In Womens Health
    • Kentucky
      • Bardstown, Kentucky, États-Unis, 40004
        • Flaget Memorial Hospital
      • Lexington, Kentucky, États-Unis, 40509
        • Saint Joseph Hospital East
      • London, Kentucky, États-Unis, 40741
        • Saint Joseph London
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70112
        • Tulane University Health Sciences Center
      • New Orleans, Louisiana, États-Unis, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, États-Unis, 70112
        • Louisiana State University Health Science Center
      • Shreveport, Louisiana, États-Unis, 71103
        • LSU Health Sciences Center at Shreveport
    • Maine
      • Augusta, Maine, États-Unis, 04330
        • Harold Alfond Center for Cancer Care
      • Belfast, Maine, États-Unis, 04915
        • Waldo County General Hospital
      • Biddeford, Maine, États-Unis, 04005
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
      • Rockport, Maine, États-Unis, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, États-Unis, 04073
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
      • Scarborough, Maine, États-Unis, 04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Baltimore, Maryland, États-Unis, 21204
        • Greater Baltimore Medical Center
      • Easton, Maryland, États-Unis, 21601
        • University of Maryland Shore Medical Center at Easton
    • Massachusetts
      • Burlington, Massachusetts, États-Unis, 01805
        • Lahey Hospital and Medical Center
      • Winchester, Massachusetts, États-Unis, 01890
        • Winchester Hospital
    • Michigan
      • Grand Rapids, Michigan, États-Unis, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, États-Unis, 49503
        • Mercy Health Saint Mary's
      • Reed City, Michigan, États-Unis, 49677
        • Spectrum Health Reed City Hospital
      • Traverse City, Michigan, États-Unis, 49684
        • Munson Medical Center
      • Wyoming, Michigan, États-Unis, 49519
        • Metro Health Hospital
    • Minnesota
      • Burnsville, Minnesota, États-Unis, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, États-Unis, 55337
        • Minnesota Oncology - Burnsville
      • Coon Rapids, Minnesota, États-Unis, 55433
        • Mercy Hospital
      • Deer River, Minnesota, États-Unis, 56636
        • Essentia Health - Deer River Clinic
      • Duluth, Minnesota, États-Unis, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, États-Unis, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, États-Unis, 55432
        • Unity Hospital
      • Hibbing, Minnesota, États-Unis, 55746
        • Essentia Health Hibbing Clinic
      • Maple Grove, Minnesota, États-Unis, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, États-Unis, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, États-Unis, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, États-Unis, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, États-Unis, 55407
        • Abbott-Northwestern Hospital
      • Monticello, Minnesota, États-Unis, 55362
        • Monticello Cancer Center
      • Robbinsdale, Minnesota, États-Unis, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, États-Unis, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, États-Unis, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, États-Unis, 55102
        • United Hospital
      • Sandstone, Minnesota, États-Unis, 55072
        • Essentia Health Sandstone
      • Stillwater, Minnesota, États-Unis, 55082
        • Lakeview Hospital
      • Virginia, Minnesota, États-Unis, 55792
        • Essentia Health Virginia Clinic
      • Willmar, Minnesota, États-Unis, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, États-Unis, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, États-Unis, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Rolla, Missouri, États-Unis, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Springfield, Missouri, États-Unis, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, États-Unis, 63131
        • Missouri Baptist Medical Center
    • Nebraska
      • Grand Island, Nebraska, États-Unis, 68803
        • CHI Health Saint Francis
    • New Hampshire
      • Nashua, New Hampshire, États-Unis, 03060
        • Saint Joseph Hospital
    • New York
      • New York, New York, États-Unis, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Asheboro, North Carolina, États-Unis, 27203
        • Randolph Hospital
      • Asheville, North Carolina, États-Unis, 28803
        • AdventHealth Infusion Center Asheville
      • Burlington, North Carolina, États-Unis, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Clinton, North Carolina, États-Unis, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Clyde, North Carolina, États-Unis, 28721
        • AdventHealth Infusion Center Haywood
      • Gastonia, North Carolina, États-Unis, 28054
        • CaroMont Regional Medical Center
      • Goldsboro, North Carolina, États-Unis, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Greensboro, North Carolina, États-Unis, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, États-Unis, 28792
        • AdventHealth Hendersonville
      • Jacksonville, North Carolina, États-Unis, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • New Bern, North Carolina, États-Unis, 28561
        • CarolinaEast Medical Center
      • Pinehurst, North Carolina, États-Unis, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Rocky Mount, North Carolina, États-Unis, 27804
        • Nash General Hospital
      • Supply, North Carolina, États-Unis, 28462
        • NHRMC Radiation Oncology - Supply
      • Wilmington, North Carolina, États-Unis, 28401
        • New Hanover Regional Medical Center/Zimmer Cancer Center
    • North Dakota
      • Minot, North Dakota, États-Unis, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, États-Unis, 44307
        • Cleveland Clinic Akron General
      • Cincinnati, Ohio, États-Unis, 45220
        • Good Samaritan Hospital - Cincinnati
    • Oregon
      • Portland, Oregon, États-Unis, 97227
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Phoenixville, Pennsylvania, États-Unis, 19460
        • Phoenixville Hospital
    • Rhode Island
      • Warwick, Rhode Island, États-Unis, 02886
        • Kent Hospital
    • South Carolina
      • Anderson, South Carolina, États-Unis, 29621
        • AnMed Health Cancer Center
      • Bluffton, South Carolina, États-Unis, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Boiling Springs, South Carolina, États-Unis, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Florence, South Carolina, États-Unis, 29506
        • McLeod Regional Medical Center
      • Gaffney, South Carolina, États-Unis, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, États-Unis, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, États-Unis, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, États-Unis, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, États-Unis, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, États-Unis, 29601
        • Saint Francis Hospital
      • Greer, South Carolina, États-Unis, 29650
        • Prisma Health Cancer Institute - Greer
      • Greer, South Carolina, États-Unis, 29651
        • Gibbs Cancer Center-Pelham
      • Hilton Head Island, South Carolina, États-Unis, 29926-3827
        • South Carolina Cancer Specialists PC
      • Seneca, South Carolina, États-Unis, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, États-Unis, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, États-Unis, 29379
        • MGC Hematology Oncology-Union
    • Tennessee
      • Cookeville, Tennessee, États-Unis, 38501
        • Cookeville Regional Medical Center
      • Kingsport, Tennessee, États-Unis, 37660
        • Ballad Health Cancer Care - Kingsport
    • Texas
      • Lubbock, Texas, États-Unis, 79415
        • UMC Cancer Center / UMC Health System
      • Lubbock, Texas, États-Unis, 79430
        • Texas Tech University Health Sciences Center-Lubbock
    • Virginia
      • Bristol, Virginia, États-Unis, 24201
        • Wellmont Medical Associates-Bristol
      • Charlottesville, Virginia, États-Unis, 22908
        • University of Virginia Cancer Center
      • Mechanicsville, Virginia, États-Unis, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, États-Unis, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, États-Unis, 23226
        • Bon Secours Saint Mary's Hospital
    • Washington
      • Issaquah, Washington, États-Unis, 98029
        • Swedish Cancer Institute-Issaquah
      • Port Townsend, Washington, États-Unis, 98368
        • Jefferson Healthcare
    • Wisconsin
      • Ashland, Wisconsin, États-Unis, 54806
        • Duluth Clinic Ashland
      • New Richmond, Wisconsin, États-Unis, 54017
        • Cancer Center of Western Wisconsin

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Participants with stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer

La description

Inclusion Criteria:

  • Patients must have stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer based on clinical or pathologic evaluation. Patients with Stage IV disease are not eligible.

  • Patients must be planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for treatment of breast or ovarian cancer, or paclitaxel chemotherapy regimen for treatment of breast, non-small cell lung, or ovarian cancer) within 14 days after registration. (Note that docetaxel or paclitaxel may be administered with a non-neurotoxic chemotherapy, such as cyclophosphamide, and/or biologic agent, such as trastuzumab, and/or carboplatin. Additionally, nab-paclitaxel may not be substituted for paclitaxel for purposes of this study.)

  • Patients who will receive treatment in the setting of any other clinical trial are eligible as long as it is one of the study-approved regimens. Patients may receive additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study.

  • Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid (vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen prior to registration. (Note that while patients must not have received carboplatin in the past, patients may receive a carboplatin-containing regimen after registration as part of the docetaxel or paclitaxel regimen.)

  • Patients who can complete Patient-Reported Outcome (PRO) instruments in English or Spanish must:

    • Agree to complete PROs at all scheduled assessments
    • Complete the baseline PRO forms prior to registration

  • Patients with pre-existing neuropathy are eligible, including those with diabetes and neurological conditions such as multiple sclerosis or Parkinson?s disease.

  • Patients must agree to submit required specimens for defined translational medicine.

  • Patients must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With patient?s consent, specimens must be submitted.

  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Observational (non-study chemo, questionnaire, assessments)

Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.
Médicament: Chemotherapy

Given chemotherapy regimen

Autres noms:
  • Chimio
  • Chimiothérapie (NOS)
  • Chimiothérapie, Cancer, Général
Autre: Functional Assessment

Functional and sensory clinician assessments

Autre: Questionnaire Administration

Patient and physician reported responses

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Development of Peripheral Neuropathy
Délai: Up to 24 weeks

Will be measured as an absolute increase of >= 8 points over the baseline chemotherapy-induced peripheral neuropathy (CIPN)-20 sensory neuropathy subscale score. Will be collected before or at the 24-week assessment..
Up to 24 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
CIPN Symptoms
Délai: Up to 52 weeks

Patients experiencing a treatment change attributed to CIPN symptoms
Up to 52 weeks
Dose Changes
Délai: Up to 52 weeks

Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)
Up to 52 weeks
Health-related Quality of Life
Délai: Up to 52 weeks

Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.
Up to 52 weeks
Visual Analog Toxicity Score
Délai: Up to 52 weeks

Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead).
Up to 52 weeks
Patient Reported Symptom
Délai: Up to 52 weeks

Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 [no burden at all] to 10 [a great burden]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 [no burden at all] to 10 [a great burden]), 2) to assess severity of side effects from cancer treatment (scale 0 [no side effects]) to 10 [side effects extremely severe and unbearable]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 [side effects not severe at all] to 10 [side effects extremely severe and unbearable]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 [no burden at all] to 10 [a great burden]).
Up to 52 weeks
Leisure-time Exercise Habits
Délai: Up to 52 weeks

Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI > 24) and insufficiently active (LSI < 23) categories.
Up to 52 weeks
Patient-Reported Outcomes
Délai: Up to 52 weeks

Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE [CTCAE Version 5.0]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days".
Up to 52 weeks
National Cancer Institute-Common Terminology Criteria for Adverse Events
Délai: Up to 52 weeks

The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range.

Participants will only be graded for the event types listed above, so these will only be reported as an outcome measure, and will not appear in the adverse events section of this report.
Up to 52 weeks
Assess Incidence of CIPN
Délai: Up to 52 weeks

Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.
Up to 52 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

SWOG Cancer Research Network

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Meghna S Trivedi, SWOG Cancer Research Network

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 mai 2019

Achèvement primaire (Réel)

8 avril 2025

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

1 mai 2019

Première soumission répondant aux critères de contrôle qualité

3 mai 2019

Première publication (Réel)

6 mai 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • S1714
  • UG1CA189974 (Subvention/contrat des NIH des États-Unis)
  • S1714 (Autre identifiant: CTEP)
  • NCI-2018-01568 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • SWOG-S1714 (Autre identifiant: DCP)
  • S1714 (Autre identifiant: SWOG)

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