- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00985400
Doctor-Recommended Home-Based Exercise Program or Relaxation Training in Improving Physical Function and Controlling Symptoms in Patients With Stage IV or Recurrent Colon Cancer That Cannot Be Removed By Surgery
Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
If you are in the exercise group, you will receive a doctor's recommendation to exercise (in-person advice and letters), newsletters on behavior change methods, resistance bands, a pedometer, and telephone counseling. A pedometer is a small device used to measure the number of steps you take.
If you are in the relaxation group, you will receive a doctor's recommendation to practice relaxation training (in-person advice and letters), newsletters on behavior change methods, written and video instructions for doing the relaxation techniques, and telephone counseling.
If you are in the Exercise Group:
- You will receive advice from your doctor (in person), physician's assistant, or other mid-level provider about exercising. You will be given advice on the use of your pedometer and resistance bands provided to you in this study, about the exercises provided and about keeping track of your progress on the exercise logs provided to you. You will also be given this advice in a letter.
- You will receive encouragement and support from a telephone counselor. The telephone counselor will contact you once a week for the first 4 weeks and then once a month for 12 weeks. The call will take about 5 minutes to complete.
- You will receive newsletters with stories about other cancer survivor experiences.
- You will be do resistance exercises using the resistance bands 2 days a week.
If you are in the Relaxation Group:
- You will receive advice from your doctor (in person), physician's assistant or other mid-level provider about relaxation techniques. You will be given advice on practicing the breathing and meditation techniques provided to you in this study, on how long and how often you are performing your relaxation techniques, and on keeping track of your relaxation practice on the relaxation logs provided to you. -You will also be given this advice in a letter.
- You will receive encouragement and support from a telephone counselor. The telephone counselor will contact you once a week for the first 4 weeks and then once a month for 12 weeks. The call will take about 5 minutes to complete.
- You will receive newsletters with stories about other cancer survivor experiences.
- You will be perform the relaxation techniques at least 15 minutes a day for 5-7 days a week.
All participants will continue the group exercises or relaxation techniques for 16 weeks.
Follow-Up Visit:
You will have a follow-up visit during Weeks 16-20. At this visit, you will complete the following tests and procedures:
- Your medical history will be recorded.
- Your performance status will be recorded.
- You will complete the 11 questionnaires.
- You will complete the exercise tests to measure how your body uses oxygen, to test your lower body strength, to test your upper body strength, and to test your flexibility and balance.
Length of Study:
You will remain on study for 16-20 weeks.
This is an investigational study.
Up to 154 patients will take part in this multicenter study. Up to 154 may be enrolled at MD Anderson.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030-4009
- University of Texas MD Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of stage IV or recurrent colorectal cancer
- Age >/= 18 years
- ECOG performance status of 0 -1
- Able to communicate in English or Spanish
- Able to give informed consent
- Adequate organ function -Total bilirubin < 1.5 x the institutional upper-normal limits (IUNL); AST (SGOT) and/or ALT (SGPT) < 2.5 x IUNL; Patients with liver metastasis AST/ (SGOT) and/or ALT (SGPT) < 5 x IUNL
- Adequate bone marrow function: - Absolute neutrophil count > 1,000/microLiters; Platelets > 50,000/microLiters
- Able to ambulate without assistance
- Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions.
Exclusion Criteria:
- Major surgery in the past 8 weeks
- Medical contraindications to home-based exercise as defined by the treating physician
- Symptomatic Bone Metastases
- Unstable Angina (current symptomatic angina at time of enrollment)
- Class III/IV heart failure according to NYHA classification system
- Pulmonary conditions that require oxygen
- Unable to ambulate without assistance (cane, walker, etc)
- Exercising at a moderate-vigorous intensity for 150 minutes or more per week, exercising at a vigorous intensity for more than 20 minutes on 3 or more days per week, or performing resistance exercises for more than 20 minutes per day on two or more days per week for 3 months or more.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Exercise Program
Arm I (exercise program): Oncologist advice; Resistance bands & pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks.
Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day.
Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention.
|
Altri nomi:
Resistance exercising using resistance bands 2 days per week, and brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day
Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.
Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising.
They will also be given this advice in a letter.
|
Sperimentale: Relaxation Intervention
Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery.
Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks.
Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I.
|
Altri nomi:
Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.
Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising.
They will also be given this advice in a letter.
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Recruitment rate
Lasso di tempo: 3 year study period
|
3 year study period
|
Patient retention
Lasso di tempo: 3 year study period
|
3 year study period
|
Program and assessment implementation
Lasso di tempo: 3 year study period
|
3 year study period
|
Patient adherence to behavioral recommendations
Lasso di tempo: Up to 20 weeks
|
Up to 20 weeks
|
Effect size of the exercise intervention on physical function
Lasso di tempo: Up to 20 weeks
|
Up to 20 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Effect size of the exercise intervention on symptoms and quality of life
Lasso di tempo: Up to 20 weeks
|
Up to 20 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Karen Basen-Engquist, PhD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2009-0288
- MDA-2009-0288
- CDR0000654446 (Altro identificatore: NCI Clinical Trials)
- NCI-2011-02280 (Identificatore di registro: NCI CTRP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro colorettale
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutanteStadio III Adenocarcinoma della prostata AJCC v7 | Stadio II Adenocarcinoma prostatico AJCC v7 | Fase I Adenocarcinoma della prostata American Joint Committee on Cancer (AJCC) v7Stati Uniti
Prove cliniche su Amministrazione del questionario
-
Cairn DiagnosticsCompletato
-
University of California, San FranciscoNational Institute of Allergy and Infectious Diseases (NIAID); Stanford University e altri collaboratoriNon ancora reclutamentoMalaria | Malaria, VivaxPerù
-
Pyae Linn AungUniversity of South Florida; Mahidol UniversityAttivo, non reclutanteMalaria | Plasmodium Vivax | Myanmar | Amministrazione farmaceutica di massa | PrimachinaBirmania
-
Universitas Negeri SemarangMinistry of Research, Technology and Higher Education, Republic of IndonesiaSconosciutoLo stress ossidativo | Sforzo; EccessoIndonesia
-
University Hospital PadovaCompletatoSindrome da distress respiratorio, neonatoItalia
-
Washington University School of MedicineCompletatoFilariosi linfatica | Oncocercosi | Infezioni da elminti trasmessi dal suolo (STH).Liberia