Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
STRONG-PCS
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Aug 2023
Typical duration for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2023
CompletedStudy Start
First participant enrolled
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 1, 2026
March 1, 2026
4 years
August 14, 2023
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
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.
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.
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).
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).
at 8 weeks
Secondary Outcomes (6)
Malnutrition-Significant weight loss
90 days
Malnutrition - Low BMI
at Baseline, 30, 60 and 90 days
Malnutrition - Low Skeletal Muscle Mass
At baseline, 30, 60 and 90 days
Quality of Life
at Baseline, 4, 8 and 12 weeks
Hospital Readmissions
30, 60 and 90 days post-hospital discharge
- +1 more secondary outcomes
Study Arms (2)
STRONG-PCS Intervention
EXPERIMENTALParticipants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
Usual Care
ACTIVE COMPARATORParticipants will be referred for nutrition counseling from a dietitian based on clinical discretion.
Interventions
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
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.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Publications (1)
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.
PMID: 41605580DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kea Turner, PhD
Moffitt Cancer Center
- PRINCIPAL INVESTIGATOR
Pamela J Hodul, MD
Moffitt Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2023
First Posted
August 21, 2023
Study Start
August 14, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03