Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT05746195
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2023-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-11', 'releaseDate': '2025-11-26'}], 'estimatedResultsFirstSubmitDate': '2025-11-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-27', 'size': 240650, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-03T02:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median response rate to text messages', 'timeFrame': 'Up to 12 weeks', 'description': "Participants' responses to text messages that ask for a response will be quantified using medians and interquartile range (IQR). The intervention will be determined feasible if the median response proportion to text messages that ask for a reply is \\>= 70%."}, {'measure': 'Overall median score on the System Usability Scale (SUS)', 'timeFrame': 'At 12 weeks', 'description': "The system usability is comprised of 10 questions assessing participants perceived usability of the intervention. Each item is scored on a scale of 1 (strongly disagree) to 5 ( strongly agree). The SUS yields a single number representing a composite measure of the overall usability of the text messaging system. To calculate the SUS score, Each item's score contribution will ultimately range from 0 to 4 (For items 1,3,5,7,and 9 the score contribution is the item score minus 1 and for items 2,4,6,8 and 10, the contribution is the item score minus 5). The sum of the scores are then multiplied by 2.5 to obtain the overall value. SUS scores have a range of 0 to 100 with a score \\> 68 indicating above average usability."}, {'measure': 'Overall score on the Acceptability of Intervention Measure (AIM)', 'timeFrame': 'At 12 weeks', 'description': 'The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \\>= 4.'}, {'measure': 'Overall score on the Intervention Appropriateness Measure (IAM)', 'timeFrame': 'At 12 weeks', 'description': 'The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \\>= 4.'}, {'measure': 'Feasibility of Intervention Measure (FIM)', 'timeFrame': 'At 12 weeks', 'description': 'The FIM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \\>= 4.'}], 'secondaryOutcomes': [{'measure': 'Change in percent of grains that are whole reported on the Food Frequency Questionnaire (FFQ)', 'timeFrame': 'Up to 12 weeks', 'description': 'The FFQ will ask about diet in the past 3 months. For each item, participants will be asked to report how often, on average, they ate the specified portion size in the past 3 months. Participants can choose from frequency options ranging from never or less than once per month to \\>=6 times a day. To compute calorie and nutrient intakes, multiply the frequency of consumption of each food by the amount of each nutrient in the specified portion size using composition values from the U.S. Department of Agriculture and other sources. Percent of grains that are whole = servings per day of whole grains/(servings per day of refined grains + servings per day of whole grains) will be reported over time'}, {'measure': 'Change in mean total daily fiber intake (g/d) reported on the Food Frequency Questionnaire (FFQ)', 'timeFrame': 'Up to 12 weeks', 'description': 'The FFQ will ask about diet in the past 3 months. For each item, participants will be asked to report how often, on average, they ate the specified portion size in the past 3 months. Participants can choose from frequency options ranging from never or less than once per month to \\>=6 times a day. To compute calorie and nutrient intakes, multiply the frequency of consumption of each food by the amount of each nutrient in the specified portion size using composition values from the U.S. Department of Agriculture and other sources. The mean total daily fiber intake and 95% confidence intervals will be reported over time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Adenocarcinoma', 'Colorectal Carcinoma', 'Rectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': "This clinical trial evaluates whether an adaptive text-message intervention is useful in helping survivors of colorectal cancers (CRC) eat more whole grain foods and less refined grain foods. Most CRC survivors don't achieve the recommended intakes of whole grains or fiber, even though there is strong evidence that a high-fiber diet rich in whole grains lowers the risk of death from CRC. Dietary interventions are a promising approach for reducing death from CRC, and text message interventions specifically are a promising tool for reaching diverse populations. This trial evaluates a text-message based dietary intervention that continuously adapts message content to be specifically tailored for the participant for increasing whole grain consumption.", 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. Determine the intervention's feasibility and acceptability.\n\nSECONDARY OBJECTIVES:\n\nI. Estimate the effect of the intervention on the percent of grains consumed that are whole.\n\nII. Estimate the effect of the intervention on total fiber intake (grams per day \\[g/d\\]).\n\nEXPLORATORY OBJECTIVE:\n\nI. Assess convergence of the reinforcement learning (RL) algorithm.\n\nOUTLINE:\n\nPatients receive nutrition education materials and then receive the adaptive text message intervention for 12 weeks on study. Patients who are food insecure also receive resources for food banks, information about meal delivery programs, and support for applying for Supplemental Nutrition Assistance Program (SNAP) benefits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Subject has provided informed consent.\n3. Diagnosis of colon or rectal adenocarcinoma.\n4. Not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy) during the study period.\n5. At least 6 weeks since a major surgery and fully recovered.\n6. Owns a mobile phone and is willing and able to receive and send text messages.\n7. Able to speak/read English or Spanish.\n8. Based on a screening survey, eat grains and =\\<50% of total grains are whole grains.\n\nExclusion Criteria:\n\n1\\. Does not meet any of the above inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05746195', 'briefTitle': 'Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Use of Text Messages to Increase Whole Grain Consumption in Colorectal Cancer', 'orgStudyIdInfo': {'id': '224523'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00870', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}, {'id': 'R21CA263539', 'link': 'https://reporter.nih.gov/quickSearch/R21CA263539', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text message intervention', 'description': 'Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake. Participants will also complete semi-structured follow-up interviews and study related questionnaires.', 'interventionNames': ['Behavioral: Dietary intervention via Text Messaging', 'Other: Survey Administration', 'Behavioral: Nutrition Education']}], 'interventions': [{'name': 'Dietary intervention via Text Messaging', 'type': 'BEHAVIORAL', 'description': 'Text messages will be sent to participants cell phones using the HealthySMS platform', 'armGroupLabels': ['Text message intervention']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Various questionnaires evaluating participants dietary habits and use of study intervention will be administered', 'armGroupLabels': ['Text message intervention']}, {'name': 'Nutrition Education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive nutrition education materials', 'armGroupLabels': ['Text message intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Erin Van Blarigan, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-26', 'type': 'RELEASE'}, {'date': '2025-12-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of California, San Francisco'}}}}