Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS) (STRONG-PCS)

June 30, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STRONG-PCS Intervention
Participants 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.
Behavioral: Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Behavioral: Nutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
Behavioral: Survey
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.
Active Comparator: Usual Care
Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.
Behavioral: Nutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
Behavioral: Survey
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate - Feasibility
Time Frame: Up to 48 months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Up to 48 months
Retention Rate - Feasibility
Time Frame: at 8 weeks
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
Time Frame: at 8 weeks
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
Time Frame: at 8 weeks
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
Time Frame: at 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malnutrition-Significant weight loss
Time Frame: 90 days
Significant weight loss is defined as >5% and >10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits.
90 days
Malnutrition - Low BMI
Time Frame: at Baseline, 30, 60 and 90 days
Low BMI will be defined as <20kg/m² for individuals <70 years old and <22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.
at Baseline, 30, 60 and 90 days
Malnutrition - Low Skeletal Muscle Mass
Time Frame: At baseline, 30, 60 and 90 days
Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males.
At baseline, 30, 60 and 90 days
Quality of Life
Time Frame: at Baseline, 4, 8 and 12 weeks
Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the 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 score indicates a better quality of life.
at Baseline, 4, 8 and 12 weeks
Hospital Readmissions
Time Frame: 30, 60 and 90 days post-hospital discharge
Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge.
30, 60 and 90 days post-hospital discharge
Malnutrition -Nutritional Status
Time Frame: at Baseline, 30, 60 and 90 days
Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished).
at Baseline, 30, 60 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Kea Turner, PhD, Moffitt Cancer Center
  • Principal Investigator: Pamela J Hodul, MD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-22476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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