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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

2022년 3월 29일 업데이트: 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).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

154

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 설문지 관리
다른 이름들:
  • 조사
행동: 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
행동: 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.
다른: 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.
실험적: 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.
다른: 설문지 관리
다른 이름들:
  • 조사
행동: 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.
다른: 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.
행동: Relaxation Program
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

결과 측정
기간
Effect size of the exercise intervention on symptoms and quality of life
기간: Up to 20 weeks
Up to 20 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

M.D. Anderson Cancer Center

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Karen Basen-Engquist, PhD, M.D. Anderson Cancer Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2010년 11월 5일

기본 완료 (예상)

2023년 3월 31일

연구 완료 (예상)

2023년 3월 31일

연구 등록 날짜

최초 제출

2009년 9월 25일

QC 기준을 충족하는 최초 제출

2009년 9월 25일

처음 게시됨 (추정)

2009년 9월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 3월 29일

마지막으로 확인됨

2022년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2009-0288
  • MDA-2009-0288
  • CDR0000654446 (기타 식별자: NCI Clinical Trials)
  • NCI-2011-02280 (레지스트리 식별자: NCI CTRP)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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