Nutrition Support Program for Gastrointestinal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Psychiatric, Neurological, Secondary cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the STRONG program can assist individuals with gastrointestinal cancer undergoing chemotherapy and surgery. The program provides nutrition support through dietician consultations, daily food tracking via a smartphone app, and questionnaires for feedback. It seeks participants who have had colorectal or appendiceal cancer, received specific cancer treatments at Moffitt, and are currently on an oral diet. The trial excludes individuals with psychiatric or neurological disorders that could hinder participation or those receiving certain types of nutrition post-surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve cancer care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the STRONG program is safe for participants with gastrointestinal cancer?

Research has shown that nutrition support for patients with gastrointestinal cancer is generally safe. Although specific safety data for the STRONG program is not available, similar programs have been used without major issues. These programs aim to enhance nutrition, helping patients remain strong during treatment.

The STRONG program involves meetings with a dietitian and using a smartphone app to track dietary intake. No reports of harmful effects from these activities suggest that the program is well-tolerated by patients.

In summary, while specific safety data for the STRONG program is lacking, similar nutrition support methods have demonstrated safety for patients with gastrointestinal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a fresh approach to supporting gastrointestinal cancer patients through nutrition. Unlike standard care options that often focus solely on medical and surgical interventions, this program emphasizes personalized dietary consultations with a Moffitt dietician. Additionally, it integrates modern technology by using a Fitbit smartphone app for daily food intake tracking, which encourages active patient involvement and real-time dietary adjustments. By combining these innovative elements, the program aims to enhance patients' overall well-being and potentially improve treatment outcomes.

What evidence suggests that the STRONG program is effective for gastrointestinal cancer?

Research has shown that the STRONG program, which participants in this trial will follow, is easy to use and well-received by individuals with esophageal and gastroesophageal junction (GEJ) cancers. In past studies, 69% to 92% of participants found the program helpful. The STRONG program provides nutritional support through meetings with dieticians and daily food tracking via a smartphone app. The program aims to help manage nutrition during cancer treatment, which is crucial because good nutrition can aid recovery and improve treatment outcomes. While these studies focus on the program's ease of use and satisfaction, they suggest that STRONG can be a valuable tool for nutritional guidance in cancer care. ^{2 3 6 7 8}

Who Is on the Research Team?

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Ben Powers, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

The STRONG program is for individuals with gastrointestinal cancer who've had CRS-HIPEC surgery and are on an oral diet. Participants must be able to understand English and give informed consent. Those with interfering psychiatric conditions, undergoing treatment for another primary cancer, or receiving post-surgery nutrition support can't join.

Inclusion Criteria

I have been diagnosed with a type of gastrointestinal cancer.

Able to speak and read English

I have started eating solid foods again after my surgery.

Exclusion Criteria

I am currently being treated for another type of cancer.

I received nutrition through a tube or IV after surgery.

Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutrition support through the STRONG program while undergoing chemotherapy and surgical treatment

16 weeks

Consultations with a dietician, daily food diary logging, and completing questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Consultations with Moffitt Dietician
• Daily Food Intake Diary with Fitbit smartphone application
• Questionnaires

Trial Overview This study tests the STRONG program's effectiveness in providing nutritional guidance through questionnaires, consultations with a dietician, and monitoring daily food intake using a Fitbit app for patients undergoing chemotherapy and surgical treatments.

How Is the Trial Designed?

Group I: STRONG Program Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

A survey of 1001 healthcare professionals revealed that while 45.5% have recommended nutrition and diet (ND) apps to patients, a significant portion (22.5%) are unaware of such apps, indicating a need for better awareness and education about these tools.

Key features that healthcare professionals look for in ND apps include ease of use (87.1%), being free of charge (72.6%), and having validated information (69%), while barriers to adoption include concerns about inaccurate food databases and lack of local food support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. Vasiloglou, MF., Christodoulidis, S., Reber, E., et al.[2021]

The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.

Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]

This study aims to evaluate the effectiveness of early nutrition intervention delivered via telephone or mobile health (mHealth) for patients with upper gastrointestinal cancers, with a focus on improving quality of life and nutritional status over an 18-week period.

The trial involves 18 weeks of tailored nutritional support for participants, with the hypothesis that those receiving early intervention will experience more quality-adjusted life years compared to those receiving standard care, highlighting the potential of mHealth in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: study protocol of a randomised controlled trial. Hanna, L., Huggins, CE., Furness, K., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11732474/

Feasibility trial of STRONG: A digital intervention to ... All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39810840/

Feasibility trial of STRONG: A digital intervention to ... Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05675059

Study Details | NCT05675059 | Support Through Remote ... The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing ...

4. cancer.jmir.org cancer.jmir.org/2025/1/e67108/PDF

Digital Health Intervention to Reduce Malnutrition Methods: STRONG is a 12-week digital intervention in which participants received biweekly nutritional counseling with a dietitian, logged food ...

5. withpower.com withpower.com/trial/phase-gastrointestinal-cancers-11-2022-2fc07

Nutrition Support Program for Gastrointestinal Cancer Trial Overview This study tests the STRONG program's effectiveness in providing nutritional guidance through questionnaires, consultations with a dietician, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9024975/

Gastrointestinal Cancer Patient Nutritional Management According to clinical data, GI cancer patients experience weight loss and signs of malnutrition at hospital admission, since nutrient digestion ...

7. academic.oup.com academic.oup.com/jnci/article/115/8/886/7172380

nutrition as prevention for improved cancer outcomes | JNCI ... A summary of meta-analyses (18) concluded that patients with gastrointestinal cancer and sarcopenia experienced a 40% increase in major ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10290234/

Nutrition as prevention for improved cancer health outcomes Ten studies examined nutrition support in gastrointestinal cancer, using a broad range of nutrition support, including perioperative use of an oral nutrition ...