Clinical trial · Interventional
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
NCT05675059CI-TRIAL-00119876completedN/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 participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consultations with Moffitt Dietician | Behavioral | — | UNRESOLVED |
| Daily Food Intake Diary with Fitbit Smartphone application | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1: STRONG Intervention
- description
- The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
- interventionNames
- Behavioral: Consultations with Moffitt Dietician
- Behavioral: Daily Food Intake Diary with Fitbit Smartphone application
- Behavioral: Questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Group 2: Usual Care
- description
- Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.
- interventionNames
- Behavioral: Consultations with Moffitt Dietician
- Behavioral: Daily Food Intake Diary with Fitbit Smartphone application
- Behavioral: Questionnaires
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer * Receiving chemotherapy under the guidance of Moffitt * Able to speak and read English * 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 * Use of parenteral or enteral nutrition * Presence of malignant ascites
References
Publications (1)
- DERIVEDTurner K, Kim DW, Gonzalez BD, Gore LR, Gurd E, Milano J, Riccardi D, Byrne M, Al-Jumayli M, de Castria TB, Laber DA, Hoffe S, Costello J, Robinson E, Chadha JS, Rajasekhara S, Hume E, Hagen R, Nguyen OT, Nardella N, Parker N, Carson TL, Tabriz AA, Hodul P. Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2024 Feb 23;38:101271. doi: 10.1016/j.conctc.2024.101271. eCollection 2024 Apr. PMID 38440777