Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00966667
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2009-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2009-08-26', 'studyFirstSubmitQcDate': '2009-08-26', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-efficacy for changing physical activity and dietary practices', 'timeFrame': '3 yrs'}, {'measure': 'Outcome expectations with regard to physical activity and dietary practices', 'timeFrame': '3 yrs'}, {'measure': 'Behavioral self-regulation of physical activity and dietary practices', 'timeFrame': '3 yrs'}, {'measure': 'Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations)', 'timeFrame': '3 yrs'}, {'measure': 'Perceived risk of CRC recurrence', 'timeFrame': '3 yrs'}, {'measure': 'Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC)', 'timeFrame': '3 yrs'}, {'measure': 'Receipt of healthcare provider recommendations to alter physical activity and diet', 'timeFrame': '3 yrs'}, {'measure': 'Normative influences of family and friends', 'timeFrame': '3 yrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer survivor', 'stage I colon cancer', 'stage II colon cancer', 'stage III colon cancer', 'stage I rectal cancer', 'stage II rectal cancer', 'stage III rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet.\n\nPURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* To characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors.\n\nSecondary\n\n* To identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients.\n* To identify these patients' preferences regarding diet and physical activity health promotion programs.\n\nOUTLINE: This is a multicenter study.\n\nPatients complete surveys at baseline and at 3 and 6 months. A randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. The acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined.\n\nDuring each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (CRC) recurrence; emotional representations of CRC (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. Patients who received the activity monitor are asked feedback on acceptability of them.\n\nMeasures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of localized or regional colorectal cancer\n\n * Stage I, II, or III disease\n * Completed treatment within the past 6 weeks\n* No previous diagnosis of colorectal cancer\n\nPATIENT CHARACTERISTICS:\n\n* English speaking\n* No current evidence of neoplastic disease except for nonmelanoma skin cancer\n* No evidence of severe cognitive impairment\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00966667', 'briefTitle': 'Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Health Behaviors Among Individuals Diagnosed With Colorectal Cancer', 'orgStudyIdInfo': {'id': '130901'}, 'secondaryIdInfos': [{'id': 'R21CA131611', 'link': 'https://reporter.nih.gov/quickSearch/R21CA131611', 'type': 'NIH'}, {'id': 'P30CA072720', 'link': 'https://reporter.nih.gov/quickSearch/P30CA072720', 'type': 'NIH'}, {'id': 'K07CA133100', 'link': 'https://reporter.nih.gov/quickSearch/K07CA133100', 'type': 'NIH'}, {'id': 'CDR0000653167', 'type': 'OTHER', 'domain': 'NIH'}, {'id': '0220090178', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'cancer survivor', 'description': 'cancer survivor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital/University Medical Center', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08818', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'JFK Medical Center in Edison', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '07728', 'city': 'Freehold', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Centrastate Healthcare System', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'zip': '08690', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital at Hamilton', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Mountainside Hospital', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '07754', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Saint Peters University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Medical Center at Princeton', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'city': 'Somerville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital Somerset', 'geoPoint': {'lat': 40.57427, 'lon': -74.60988}}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Medical Center', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Elliot Coups, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Rutgers Cancer Institute of New Jersey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}