RecruitingInterventional

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)

NCT ID: NCT06001268Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2026-04-01

Summary

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.

Arms & interventions

BehavioralFitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
BehavioralNutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
BehavioralSurvey
Participants will take a survey at baseline and weeks 4,8,\& 12. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.

Outcome measures

Primary

Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Time frame: Up to 48 months
Retention Rate - Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Time frame: at 8 weeks
Data Collection - Feasibility
The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
Time frame: at 8 weeks
Participant Satisfaction - Acceptability
The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score \>/= 12).
Time frame: at 8 weeks
Participant Rating on Ease of Use the Mobile Application - Usability
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of \>/=60).
Time frame: at 8 weeks

Secondary

Malnutrition-Significant weight loss
Time frame: 90 days
Malnutrition - Low BMI
Time frame: at Baseline, 30, 60 and 90 days
Malnutrition - Low Skeletal Muscle Mass
Time frame: At baseline, 30, 60 and 90 days
Quality of Life
Time frame: at Baseline, 4, 8 and 12 weeks
Hospital Readmissions
Time frame: 30, 60 and 90 days post-hospital discharge
Malnutrition -Nutritional Status
Time frame: at Baseline, 30, 60 and 90 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * ≥18 years old * Diagnosis of pancreatic cancer * Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center * Discharged on an oral diet * Able to speak and read English or Spanish * Able to provide informed consent Exclusion Criteria: * Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)

Study locations (1)

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Emma Hume · Contact

813-745-6426 Emma.Hume@moffitt.org

Kea L Turner, PhD, MPH, MA · Principal Investigator

Pamela J Hodul, MD · Principal Investigator

Amir Alishahi Tabriz, MD, PhD, MPH · Sub Investigator

Brian D Gonzalez, PhD · Sub Investigator

Nate H Parker, MPH, PhD · Sub Investigator

Laurence R Gore, PhD · Sub Investigator

References

Turner K, Milano J, Santiago C, Coutinho J, Sprow O, Hume E, Nardella N, Alishahi Tabriz A, Islam JY, Hodul PJ. A patient-mediated strategy to improve nutrition care after transition from hospital to home for pancreatic cancer surgery: a pilot randomised controlled trial study protocol. BMJ Open. 2026 Jan 28;16(1):e113207. doi: 10.1136/bmjopen-2025-113207.(PubMed)