NCT00819208Befejeződött
Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer
A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 24.
Rövid összefoglaló (regiszter, angolul)
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment. PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 889 (tényleges)
- Első benyújtás
- 2009. jan. 7.
- Kezdés
- 2009. jún. 2.
- Elsődleges befejezés
- 2025. febr. 7.
- Fő szponzor
- Canadian Cancer Trials Group
- Betegségek
- Vastagbélrák
- NCT-szám
- NCT00819208
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 889
- 2009. jún. 2. és az elsődleges befejezés (2025. febr. 7.) között
- 47 helyszín, 6 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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A regiszterben nem jelölt feltételek
- DISEASE CHARACTERISTICS:
- Completely resected histologically confirmed adenocarcinoma of the colon
- High-risk stage II disease, including one of the following:
- T4 lesions
- Less than 12 sampled lymph nodes
- Poorly differentiated histology
- Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit.
- Synchronous primary colon cancer allowed
- Adjuvant chemotherapy treatment for colon cancer with a 5-fluorouracil- based regimen received with an intent to provide a complete course of treatment. While one current standard is 24 weeks of treatment, patients who are pre-planned to receive a shorter duration of chemotherapy, including as part of a research study will also be permitted. The actual treatment received may be less than 24 weeks; participants must have received a minimum of one treatment cycle.
- Chemotherapy must have been completed (i.e. last dose received) a minimum of 60 days and a maximum of 180 days prior to registration.
- Carcinoembryonic antigen (CEA) ≤ 5 μg/L
- Current physical activity levels do not meet the recommended guidelines (≥ 150 minutes of moderate-to-vigorous or ≥ 75 minutes of vigorous physical activity/week) as calculated using the Leisure Time Exercise Questionnaire (LTEQ)
- Completion of chest x-ray or CT, and CT, MRI or ultrasound of abdomen within 60 days of registration; these imaging tests must not show evidence of metastatic or locally-recurrent colon cancer.
- Complete one of the following: (a) at least 2 stages of the submaximal exercise test with an acceptable heart rate and blood pressure response as defined in Appendix XII or (b) the 6 minute walk test with an acceptable heart rate and blood pressure response
- No rectal cancer
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute granulocyte count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 100 g/L
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 times ULN
- ALT < 2 times ULN
- Not pregnant or planning to become pregnant within the next 3 years
- Able (i.e., sufficiently fluent) and willing to effectively communicate with the physical activity consultant affiliated with the originating cancer center
- Able (i.e., sufficiently fluent in English or French) and willing to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics, and physical activity questionnaires and logs
- Able to complete the baseline exercise test
- No significant comorbid conditions precluding participation in a physical activity program as determined by the investigator
- Likely to participate in a physical activity program, as assessed by the investigator
- No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, other solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma curatively treated with no evidence of disease for > 5 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy as a component of treatment for primary tumor
- No concurrent treatment with additional chemotherapy or radiation
- No concurrent treatment with any medications deemed by the investigator as likely to preclude participation in a physical activity program
- No concurrent anticancer treatment including chemotherapy, biological, or targeted agents
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (47)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | Ausztrália | Ismeretlen állapot |
| Armidale Hospital | Armidale | Ausztrália | Ismeretlen állapot |
| Bankstown-Lidcombe Hospital | Bankstown | Ausztrália | Ismeretlen állapot |
| Flinders Medical Centre | Bedford Park | Ausztrália | Ismeretlen állapot |
| Macarthur Cancer Therapy Centre - Campbelltown Hospital | Campbelltown | Ausztrália | Ismeretlen állapot |
| Royal Prince Alfred Hospital | Camperdown | Ausztrália | Ismeretlen állapot |
| North Coast Cancer Institute Coffs Harbour | Coffs Harbour | Ausztrália | Ismeretlen állapot |
| Concord Repatriation General Hospital | Concord | Ausztrália | Ismeretlen állapot |
| St Vincent's Hospital Melbourne | Fitzroy | Ausztrália | Ismeretlen állapot |
| Royal Brisbane and Women's Hospital | Herston | Ausztrália | Ismeretlen állapot |
| Liverpool Hospital | Liverpool | Ausztrália | Ismeretlen állapot |
| Newcastle Private Hospital | Newcastle | Ausztrália | Ismeretlen állapot |
| Royal Perth Hospital | Perth | Ausztrália | Ismeretlen állapot |
| North Coast Cancer Institute - Port Macquarie | Port Macquarie | Ausztrália | Ismeretlen állapot |
| Royal North Shore Hospital | St Leonards | Ausztrália | Ismeretlen állapot |
| Tamworth Hospital | Tamworth | Ausztrália | Ismeretlen állapot |
| Riverina Cancer Care Centre | Wagga Wagga | Ausztrália | Ismeretlen állapot |
| Sydney Adventist Hospital | Wahroonga | Ausztrália | Ismeretlen állapot |
| The Queen Elizabeth Hospital | Woodville | Ausztrália | Ismeretlen állapot |
| Princess Alexandra | Woolloongabba | Ausztrália | Ismeretlen állapot |
| Tom Baker Cancer Centre | Calgary | Kanada | Ismeretlen állapot |
| Cross Cancer Institute | Edmonton | Kanada | Ismeretlen állapot |
| Horizon Health Network | Fredericton | Kanada | Ismeretlen állapot |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Kanada | Ismeretlen állapot |
| Kingston Health Sciences Centre | Kingston | Kanada | Ismeretlen állapot |
| Grand River Regional Cancer Centre | Kitchener | Kanada | Ismeretlen állapot |
| - | Lévis | Kanada | Ismeretlen állapot |
| London Regional Cancer Program | London | Kanada | Ismeretlen állapot |
| Trillium Health Partners - Credit Valley Hospital | Mississauga | Kanada | Ismeretlen állapot |
| The Moncton Hospital | Moncton | Kanada | Ismeretlen állapot |
| Stronach Regional Health Centre at Southlake | Newmarket | Kanada | Ismeretlen állapot |
| Ottawa Hospital Research Institute | Ottawa | Kanada | Ismeretlen állapot |
| Allan Blair Cancer Centre | Regina | Kanada | Ismeretlen állapot |
| Regional Health Authority B, Zone 2 | Saint John | Kanada | Ismeretlen állapot |
| Saskatoon Cancer Centre | Saskatoon | Kanada | Ismeretlen állapot |
| Niagara Health System | St. Catharines | Kanada | Ismeretlen állapot |
| Sinai Health System | Toronto | Kanada | Ismeretlen állapot |
| Odette Cancer Centre | Toronto | Kanada | Ismeretlen állapot |
| Toronto Rehab | Toronto | Kanada | Ismeretlen állapot |
| BCCA - Vancouver Cancer Centre | Vancouver | Kanada | Ismeretlen állapot |
| CancerCare Manitoba | Winnipeg | Kanada | Ismeretlen állapot |
| - | Montpellier | Franciaország | Ismeretlen állapot |
| Belfast City Hospital | Belfast | Egyesült Királyság | Ismeretlen állapot |
| Exercise Medicine Center for Diabetes and Cancer | Seoul | Dél-Korea | Ismeretlen állapot |
| University of North Carolina at Chapel Hill | Chapel Hill | Egyesült Államok | Ismeretlen állapot |
| Henry Ford Hospital | Detroit | Egyesült Államok | Ismeretlen állapot |
| Dartmouth Hitchcock | Lebanon | Egyesült Államok | Ismeretlen állapot |
Kapcsolódó publikációk
- Effects of a structured exercise program on motivational outcomes in patients with colon cancer.J Natl Cancer Inst · 2026 · PMID 41609410
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