STRONG Program for Cancer Patients

March 18, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute

STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
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
Behavioral: Questionnaires
Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the STRONG Program
Time Frame: at 12 weeks
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
Time Frame: at 16 weeks
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
Time Frame: at 16 weeks
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
Time Frame: at 16 weeks
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

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

Investigators

  • Principal Investigator: Ben Powers, MD, Moffitt Cancer Center
  • Principal Investigator: Kea Turner, PhD, 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.

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)

December 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-22117

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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