Спонсор: University of Rochester NCORP Research Base
Налично на:
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Обобщение
This phase II trial studies whether using exercise is better than the usual approach for treating chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy damages the nerves communicating between the brain, spinal cord, and the rest of the body. The usual approach for treating CIPN is treatment with drugs that help reduce symptoms of other types of neuropathy (for example, from diabetes). However, these drugs do not treat all symptoms of CIPN. Exercise may help to reduce CIPN symptoms.
Описание
PRIMARY OBJECTIVE:
I. Assess the preliminary efficacy of exercise versus (vs.) standard care for treating CIPN (via patient-reported CIPN-20 total score).
SECONDARY OBJECTIVES:
I. Assess the preliminary efficacy of exercise vs. standard care on individual symptoms of CIPN (via CIPN Symptom Inventory; i.e., numbness, tingling, burning/shooting pain, and cramping in the hands and feet).
II. Assess the preliminary efficacy of exercise vs. standard care on a clinical test of CIPN symptoms (via the tactile sensitivity in the fingers and toes).
III. Assess the effects of exercise vs. standard care on two possible CIPN mechanisms, namely interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 \[MAIA-2\] questionnaire).
EXPLORATORY OBJECTIVES:
I. Assess the effects of exercise vs. standard care on other common symptoms related to cancer, chemotherapy, and CIPN, including:
Ia. Daily Diary of symptoms of CIPN. Ib. An array of cancer and treatment symptoms (MD Anderson Symptom Inventory; MDASI).
Ic. Anxiety and depression (hospital anxiety and depression scale; HADS). Id. Pain catastrophizing (pain catastrophizing scale; PCS). Ie. Cognitive impairment (Functional Assessment of Cancer Therapy-Cognitive \[FACT-Cog\]).
If. Fatigue (brief fatigue inventory; BFI). Ig. Quality of life (Functional Assessment of Cancer Therapy - General \[FACT-G\]).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1 (EXERCISE): Participants undergo the exercise for cancer patients (EXCAP) intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5.
ARM 2 (CONTROL): Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.
Participants may optionally undergo magnetic resonance imaging (MRI) on study.
Кой може да участва
Inclusion Criteria:
* Have a diagnosis of cancer
* Have received neurotoxic chemotherapy within the past nine months (could still be on chemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy
* Report one or more symptoms of CIPN at a level of \>= 4 on the CIPN symptom inventory on the Screening Form
* Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Have at least six months life expectancy
* Be at least 18 years of age
* Be able to read and understand English
* Be able to provide written informed consent
Exclusion Criteria:
* Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance exercise program, according to the participant's physician (e.g., oncologist, primary care) or physician's designee
* Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form
* Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)
* Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant
* Are pregnant of have plans to become pregnant during the course of the study. Documentation of pregnancy and use of contraception can be obtained from the medical record.
* Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.
Интервенции
Best Practice
OTHER
Exercise Counseling
OTHER
Exercise Intervention
OTHER
Magnetic Resonance Imaging
PROCEDURE
Neuropathy Assessment
OTHER
Questionnaire Administration
OTHER
Места на провеждане
93
САЩ (93)
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Pali Momi Medical Center
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Rocky Mountain Cancer Centers-Aurora
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Strecker Cancer Center-Belpre
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Prisma Health Cancer Institute - Spartanburg
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Rocky Mountain Cancer Centers-Boulder
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Boulder Community Foothills Hospital
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Trinity Health Medical Center - Brighton
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Trinity Health IHA Medical Group Hematology Oncology - Canton
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Trinity Health Medical Center - Canton
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SIH Cancer Institute
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Physicians' Clinic of Iowa PC
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Oncology Associates at Mercy Medical Center
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Rocky Mountain Cancer Centers - Centennial
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Centralia Oncology Clinic
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Chelsea Hospital
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chesapeake Regional Medical Center
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Mercy Hospital
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Carle at The Riverfront
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Cancer Care Specialists of Illinois - Decatur
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Decatur Memorial Hospital
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The Women's Imaging Center
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Colorado Blood Cancer Institute
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Rocky Mountain Cancer Centers-Midtown
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Rocky Mountain Cancer Centers-Rose
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Mercy Medical Center - Des Moines
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Prisma Health Cancer Institute - Easley
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Crossroads Cancer Center
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Christiana Care - Union Hospital
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Rocky Mountain Cancer Centers - Swedish
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The Melanoma and Skin Cancer Institute
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Kaiser Permanente-Fresno
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Unity Hospital
Fridley , Minnesota
CaroMont Regional Medical Center
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Saint Vincent Hospital Cancer Center Green Bay
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Saint Vincent Hospital Cancer Center at Saint Mary's
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Prisma Health Cancer Institute - Butternut
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Prisma Health Cancer Institute - Faris
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Prisma Health Cancer Institute - Eastside
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Prisma Health Cancer Institute - Greer
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Hawaii Cancer Care Inc - Waterfront Plaza
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Straub Clinic and Hospital
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University of Hawaii Cancer Center
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Kapiolani Medical Center for Women and Children
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Rocky Mountain Cancer Centers-Lakewood
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Fairfield Medical Center
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University of Michigan Health - Sparrow Lansing
Lansing , Michigan
Saint Rita's Medical Center
Lima , Ohio
CaroMont Health - Lincoln Cancer Center
Lincolnton , North Carolina
Rocky Mountain Cancer Centers-Littleton
Littleton , Colorado
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia , Michigan
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree , Colorado
Rocky Mountain Cancer Centers-Longmont
Longmont , Colorado
Marietta Memorial Hospital
Marietta , Ohio
Contra Costa Regional Medical Center
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Beebe South Coastal Health Campus
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Abbott-Northwestern Hospital
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Helen F Graham Cancer Center
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Medical Oncology Hematology Consultants PA
Newark , Delaware
Licking Memorial Hospital
Newark , Ohio
Cancer Care Center of O'Fallon
O'Fallon , Illinois
Lake Regional Hospital
Osage Beach , Missouri
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst , North Carolina
Southern Ohio Medical Center
Portsmouth , Ohio
Beebe Health Campus
Rehoboth Beach , Delaware
Nash UNC HealthCare
Rocky Mount , North Carolina
Kaiser Permanente-Roseville
Roseville , California
Kaiser Permanente Downtown Commons
Sacramento , California
Kaiser Permanente-South Sacramento
Sacramento , California
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park , Minnesota
Regions Hospital
Saint Paul , Minnesota
Kaiser Permanente-Santa Teresa-San Jose
San Jose , California
Kaiser Permanente San Leandro
San Leandro , California
Kaiser San Rafael-Gallinas
San Rafael , California
Kaiser Permanente Medical Center - Santa Clara
Santa Clara , California
Prisma Health Cancer Institute - Seneca
Seneca , South Carolina
Kaiser Permanente-South San Francisco
South San Francisco , California
Missouri Baptist Medical Center
St Louis , Missouri
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay , Wisconsin
Rocky Mountain Cancer Centers-Thornton
Thornton , Colorado
Carle Cancer Center
Urbana , Illinois
Kaiser Permanente-Vallejo
Vallejo , California
Ridgeview Medical Center
Waconia , Minnesota
Kaiser Permanente-Walnut Creek
Walnut Creek , California
MedStar Georgetown University Hospital
Washington D.C. , District of Columbia
MedStar Washington Hospital Center
Washington D.C. , District of Columbia
Rice Memorial Hospital
Willmar , Minnesota
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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