Clinical trial · Interventional
The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
NCT06050395CI-TRIAL-00115979completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Handouts | Behavioral | — | UNRESOLVED |
| Follow-Up Survey | Behavioral | — | UNRESOLVED |
| Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire | Behavioral | — | UNRESOLVED |
| NutritionCoaching | Behavioral | — | UNRESOLVED |
| Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire | Behavioral | — | UNRESOLVED |
| Quality fo Life Questionnaire (FHSI) | Behavioral | — | UNRESOLVED |
| Vioscreen Food Frequency Questionnaire (FFQ) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women 18 years of age or more * Newly diagnosed, in place tumors of the pancreas * No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis) * Able to speak and read English * Able to consume food orally * Chemotherapy naive * Scheduled to receive treatment with chemotherapy * Able to provide verbal informed consent Exclusion Criteria: * Women who are pregnant * Pancreatic cancer not the primary diagnosis * Patients on enteral or parental nutrition * Patients with metastatic pancreatic cancer * Patients with evidence of impeding bowel obstruction * Patients presenting with ascites
References
Publications (0)
Data not yet available
No reference posted for this study.