Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-31 @ 12:00 PM
Study NCT ID:
NCT06050395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Effect - Quality of Life', 'timeFrame': 'at Baseline, and at 6 and 12 weeks', 'description': 'Quality of Life will be measured using the FACT-Hep questionnaire. Participants will take the Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom 8 Item Version (FHSI) questionnaire which uses a 5-point likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.'}], 'primaryOutcomes': [{'measure': 'Recruitment Rate -Feasibility', 'timeFrame': 'Up to 8 months', 'description': 'The study will be deemed feasible if \\>/= 60% of eligible participants are enrolled'}, {'measure': 'Retention Rate - Feasibility', 'timeFrame': 'at 12 weeks', 'description': 'The study will be deemed feasible if \\>/=70% of participants complete the post-intervention questionnaire'}, {'measure': 'Adherence - Feasibility', 'timeFrame': 'at 12 weeks', 'description': 'The study will be deemed feasible if average attendance is \\>/=4 weeks of sessions (out of 6) for MONITOR arm'}], 'secondaryOutcomes': [{'measure': 'Participant Satisfaction with Overall Program- Acceptability', 'timeFrame': 'at 12 weeks', 'description': 'The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant Satisfaction with Overall Program is determined by a score \\>/=3 on a 5-point scale.'}, {'measure': 'Participant intent to continue using skills- Acceptability', 'timeFrame': 'at 12 weeks', 'description': 'The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant intent to continue using skills- is determined by a score \\>/=3 on a 5-point scale.'}, {'measure': 'Participant perception of utility of knowledge gained - Acceptability', 'timeFrame': 'at 12 weeks', 'description': 'The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant perception of utility of knowledge gained is determined by a score \\>/=3 on a 5-point scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.moffitt.org/clinical-trials-research/clinical-trials/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women 18 years of age or more\n* Newly diagnosed, in place tumors of the pancreas\n* No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)\n* Able to speak and read English\n* Able to consume food orally\n* Chemotherapy naive\n* Scheduled to receive treatment with chemotherapy\n* Able to provide verbal informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant\n* Pancreatic cancer not the primary diagnosis\n* Patients on enteral or parental nutrition\n* Patients with metastatic pancreatic cancer\n* Patients with evidence of impeding bowel obstruction\n* Patients presenting with ascites'}, 'identificationModule': {'nctId': 'NCT06050395', 'briefTitle': 'The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response', 'orgStudyIdInfo': {'id': 'MCC-22523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response', 'description': 'Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.', 'interventionNames': ['Behavioral: Quality fo Life Questionnaire (FHSI)', 'Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)', 'Behavioral: NutritionCoaching', 'Behavioral: Follow-Up Survey', 'Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire', 'Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Usual Care', 'description': 'Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.', 'interventionNames': ['Behavioral: Quality fo Life Questionnaire (FHSI)', 'Behavioral: Educational Handouts', 'Behavioral: Follow-Up Survey', 'Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire', 'Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire']}], 'interventions': [{'name': 'Quality fo Life Questionnaire (FHSI)', 'type': 'BEHAVIORAL', 'description': 'Participants will take a survey at baseline and visit 2 (weeks 6-8), and visit 3 (week 10-14). The Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index-8 (FHSI) questionnaire uses a 5-point Likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.', 'armGroupLabels': ['MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response', 'Standard Usual Care']}, {'name': 'Vioscreen Food Frequency Questionnaire (FFQ)', 'type': 'BEHAVIORAL', 'description': "Participants will receive a web-based link and information to complete VioScreen, a web-based food frequency questionnaire, which allows participants to choose the average frequency of consumption of food items over a given time frame (1 month, 3 month, 1 year, etc.) on a Likert scale with choices ranging by individual questions. Total energy and nutrient intake is estimated by summing intakes from each food based on the selected portion size, reported frequency of consumption, and nutrient content of each food item. Anti-inflammatory and pro-inflammatory dietary patterns are calculated using the energy-adjusted dietary inflammatory index (DII) score to represent the inflammatory potential of an individual's overall diet, using data from FFQ responses. Higher DII scores represent more pro-inflammatory diets while lower (i.e., more negative) DII scores represent more anti-inflammatory diet.", 'armGroupLabels': ['MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response']}, {'name': 'Educational Handouts', 'type': 'BEHAVIORAL', 'description': 'Participants will receive educational handouts on diet.', 'armGroupLabels': ['Standard Usual Care']}, {'name': 'NutritionCoaching', 'type': 'BEHAVIORAL', 'description': 'Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.', 'armGroupLabels': ['MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response']}, {'name': 'Follow-Up Survey', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a custom exit/follow up survey regarding relevance, acceptability, intervention length and timing, an barriers/facilitators. This survey contains 38 questions scored from 1 -Strongly agree to 5-Strongly disagree. A lower score indicates patient satisfaction with the program and the skills and knowledge gained in the program.', 'armGroupLabels': ['MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response', 'Standard Usual Care']}, {'name': 'Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire', 'type': 'BEHAVIORAL', 'description': 'The FAACT questionnaire uses a 5 point Likert-type scale, 0=Not at all, 4=Very much. A higher score indicates better appetite and quality of life.', 'armGroupLabels': ['MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response', 'Standard Usual Care']}, {'name': 'Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Participants will complete the PROMIS-Cog form which measures self-reported cognitive deficits. The questionnaire uses a 5 point Likert-type scale, 1=Very often and 5=Never. A higher score indicates higher cognitive function.', 'armGroupLabels': ['MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response', 'Standard Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Sylvia Crowder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Pamela Hodul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}