Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-06-11 @ 3:03 PM
Study NCT ID:
NCT03063918
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2017-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-23', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Scores from the Decisional Conflict Scale', 'timeFrame': 'Up to 6 months', 'description': 'Descriptive statistics will be summarized. This analysis is exploratory only. Will use the findings to support future research related to treatment-decision making in rectal cancer.'}], 'primaryOutcomes': [{'measure': 'Acceptability assessed by semi-structured interview', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed through qualitative data analysis using conventional content analysis approach.'}, {'measure': 'Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool', 'timeFrame': 'Up to 6 months', 'description': 'Descriptive statistics will be summarized using validated scoring procedures.'}, {'measure': 'Feasibility assessed by patient enrollment', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete \\>= 80% of the study.'}, {'measure': 'Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer', 'timeFrame': 'Up to 6 months', 'description': 'Descriptive statistics will be summarized using validated scoring procedures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Survivor', 'Stage I Rectosigmoid Cancer', 'Stage II Rectosigmoid Cancer', 'Stage III Rectosigmoid Cancer']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Administer and determine the feasibility of the personalized dietary intervention.\n\nII. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.\n\nIII. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.\n\nOUTLINE:\n\nAt 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.\n\nAfter completion of study, patients are followed up for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum\n* 6 months post-treatment completion\n* Have a permanent ostomy or anastomosis\n* English-speaking\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Patients with stage IV disease will be excluded from the study\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study'}, 'identificationModule': {'nctId': 'NCT03063918', 'briefTitle': 'Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors', 'orgStudyIdInfo': {'id': '16332'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00258', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '16332', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (personalized dietary intervention)', 'description': 'At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.', 'interventionNames': ['Other: Informational Intervention', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Other: Survey Administration', 'Behavioral: Telephone-Based Intervention']}], 'interventions': [{'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive a workbook', 'armGroupLabels': ['Supportive Care (personalized dietary intervention)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (personalized dietary intervention)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (personalized dietary intervention)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (personalized dietary intervention)']}, {'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive personalized dietary intervention', 'armGroupLabels': ['Supportive Care (personalized dietary intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The University of Arizona Medical Center-University Campus', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Virginia Sun, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Hope Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}