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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Nutrition Support Program for Gastrointestinal Cancer?

Research suggests that early and intensive nutrition care, delivered via telephone or mobile application, can improve quality of life for people with upper gastrointestinal cancer. Additionally, using mobile health technologies for nutrition management is feasible and can enhance patient outcomes. ^{1 2 3 4 5}

Is the Nutrition Support Program for Gastrointestinal Cancer safe for humans?

The studies reviewed do not provide specific safety data for the Nutrition Support Program for Gastrointestinal Cancer, but they suggest that similar dietary interventions and digital health tools are generally acceptable and usable by patients and healthcare professionals. ^{1 5 6 7 8}

How does the Nutrition Support Program for Gastrointestinal Cancer differ from other treatments?

This treatment is unique because it focuses on personalized nutritional support to help patients with gastrointestinal cancer gain weight and improve their quality of life, unlike standard care which may not address these specific needs. It involves individual support and group rehabilitation, which have shown significant benefits in weight gain over time. ^{1 9 10 11 12}

Research Team

Ben Powers, MD

Principal Investigator

Moffitt Cancer Center

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The roles of the dietitian in an 18-week telephone and mobile application nutrition intervention for upper gastrointestinal cancer: a qualitative analysis. [2023]

2. England 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. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Potential benefits of early nutritional intervention in adults with upper gastrointestinal cancer: a pilot randomised trial. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Sedentary Behavior in Older Gastrointestinal Cancer Survivors: Need and Acceptability of Digital Health Interventions. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Quality of life among colorectal cancer survivors participating in a pilot randomized controlled trial of a web-based dietary intervention with text messages. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The effects of nutritional support team intervention on postoperative immune function, nutritional statuses, inflammatory responses, clinical outcomes of elderly patients with gastric cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized study of nutritional support in patients with colorectal and gastric cancer. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Accuracy of isolated nutrition indicators in diagnosing malnutrition and their prognostic value to predict death in patients with gastric and colorectal cancer: A prospective study. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Roles of nutrition risk screening and preventive enteral nutritional support before radical resection of gastric cancer]. [2009]