NCT05649969

Brief Summary

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 nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

December 6, 2022

Last Update Submit

February 5, 2026

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (4)

  • Feasibility of the STRONG Program

    Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.

    at 12 weeks

  • Acceptability of the STRONG Program

    The Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.

    at 16 weeks

  • Adherence to the STRONG Program

    Participant adherence to the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed by Fitbit dietary log data and dietician care visit data.

    at 16 weeks

  • Efficacy of STRONG Program on Treatment Outcomes

    Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission

    at 16 weeks

Study Arms (1)

STRONG Program

EXPERIMENTAL

the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.

Behavioral: Consultations with Moffitt DieticianBehavioral: Daily Food Intake Diary with Fitbit smartphone applicationBehavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.

STRONG Program
Consultations with Moffitt DieticianBEHAVIORAL

Participants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks.

STRONG Program
Daily Food Intake Diary with Fitbit smartphone applicationBEHAVIORAL

Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks

STRONG Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)
  • Peritoneal disease diagnosis
  • Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt
  • Transitioned to an oral diet post-surgery
  • Able to speak and read English
  • Able to provide informed consent

You may not qualify if:

  • Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
  • Undergoing concurrent treatment for a secondary primary cancer
  • Receipt of parenteral or enteral nutrition after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Referral and ConsultationSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Amir Alishahi Tabriz, MD, PhD, MPH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

  • Ben Powers, MD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

December 1, 2022

Primary Completion

November 30, 2023

Study Completion

January 21, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(1)