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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

29 maart 2022 bijgewerkt door: M.D. Anderson Cancer Center

Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients

The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

154

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Houston, Texas, Verenigde Staten, 77030-4009
        • University of Texas MD Anderson Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Diagnosis of stage IV or recurrent colorectal cancer
  2. Age >/= 18 years
  3. ECOG performance status of 0 -1
  4. Able to communicate in English or Spanish
  5. Able to give informed consent
  6. 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
  7. Adequate bone marrow function: - Absolute neutrophil count > 1,000/microLiters; Platelets > 50,000/microLiters
  8. Able to ambulate without assistance
  9. Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions.

Exclusion Criteria:

  1. Major surgery in the past 8 weeks
  2. Medical contraindications to home-based exercise as defined by the treating physician
  3. Symptomatic Bone Metastases
  4. Unstable Angina (current symptomatic angina at time of enrollment)
  5. Class III/IV heart failure according to NYHA classification system
  6. Pulmonary conditions that require oxygen
  7. Unable to ambulate without assistance (cane, walker, etc)
  8. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Vragenlijst administratie
Andere namen:
  • Vragenlijst
Gedragsmatig: Exercise Program
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
Gedragsmatig: Telephone-based intervention
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.
Ander: Counseling intervention
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.
Experimenteel: 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.
Ander: Vragenlijst administratie
Andere namen:
  • Vragenlijst
Gedragsmatig: Telephone-based intervention
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.
Ander: Counseling intervention
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.
Gedragsmatig: Relaxation Program
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Recruitment rate
Tijdsspanne: 3 year study period
3 year study period
Patient retention
Tijdsspanne: 3 year study period
3 year study period
Program and assessment implementation
Tijdsspanne: 3 year study period
3 year study period
Patient adherence to behavioral recommendations
Tijdsspanne: Up to 20 weeks
Up to 20 weeks
Effect size of the exercise intervention on physical function
Tijdsspanne: Up to 20 weeks
Up to 20 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Effect size of the exercise intervention on symptoms and quality of life
Tijdsspanne: Up to 20 weeks
Up to 20 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

M.D. Anderson Cancer Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Karen Basen-Engquist, PhD, M.D. Anderson Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 november 2010

Primaire voltooiing (Verwacht)

31 maart 2023

Studie voltooiing (Verwacht)

31 maart 2023

Studieregistratiedata

Eerst ingediend

25 september 2009

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2009

Eerst geplaatst (Schatting)

28 september 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

29 maart 2022

Laatst geverifieerd

1 maart 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2009-0288
  • MDA-2009-0288
  • CDR0000654446 (Andere identificatie: NCI Clinical Trials)
  • NCI-2011-02280 (Register-ID: NCI CTRP)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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