STRONG Program for Cancer Patients

NCT ID: NCT05649969

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STRONG Program

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.

Group Type EXPERIMENTAL

Consultations with Moffitt Dietician

Intervention Type BEHAVIORAL

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

Daily Food Intake Diary with Fitbit smartphone application

Intervention Type BEHAVIORAL

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

Questionnaires

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Consultations with Moffitt Dietician

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

Intervention Type BEHAVIORAL

Daily Food Intake Diary with Fitbit smartphone application

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

Intervention Type BEHAVIORAL

Questionnaires

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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 secondary primary cancer
* Receipt of parenteral or enteral nutrition after surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amir Alishahi Tabriz, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Ben Powers, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCC-22117

Identifier Type: -

Identifier Source: org_study_id