Clinical trial · Interventional
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
NCT05438927CI-TRIAL-00106841completedN/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 assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fact G Survey | Behavioral | — | UNRESOLVED |
| Fitbit Data Collection | Behavioral | — | UNRESOLVED |
| General Anxiety Disorder (GAD)-7 | Behavioral | — | UNRESOLVED |
| Nutrition Counseling | Behavioral | — | UNRESOLVED |
| Patient Health Questionnaire (PHQ)-9 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nutritional Support
- description
- Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician
- interventionNames
- Behavioral: Fitbit Data Collection
- Behavioral: Nutrition Counseling
- Behavioral: Fact G Survey
- Behavioral: General Anxiety Disorder (GAD)-7
- Behavioral: Patient Health Questionnaire (PHQ)-9
Primary outcomes (3)
- measure
- Recruitment Rate - Feasibility
- timeFrame
- 12 Months
- description
- The study will be deemed feasible if ≥ 50% of eligible participants are recruited
- measure
- Data Collection - Feasibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years old * Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer * Planning to initiate chemotherapy under the guidance of Moffitt * Able to speak and read English or Spanish * Able to provide informed consent Exclusion Criteria: * Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse) * Undergoing concurrent treatment for a second primary GI cancer * ECOG status of 2 or greater * Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer * Use of parenteral or enteral nutrition * Presence of malignant ascites * The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.
References
Publications (0)
Data not yet available
No reference posted for this study.