Nutrition Guidance Program for Gastroesophageal Cancer

Recruiting at 1 trial location

Overseen By Emma Hume

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Psychiatric disorders, Neurological disorders, Feeding tubes, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Support Through Remote Observation and Nutrition Guidance Program can reduce malnutrition in people with gastroesophageal cancer compared to regular care. Participants in the experimental group will work with a dietitian and use a Fitbit to track their food intake and activity for 90 days. The trial seeks individuals with advanced gastroesophageal cancer who are beginning treatment such as chemotherapy or radiation and can speak and read English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative nutritional support strategies that could enhance care for future patients.

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

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

What prior data suggests that the STRONG Program is safe for gastroesophageal cancer patients?

Research shows that the Support Through Remote Observation and Nutrition Guidance (STRONG) program is practical and well-received by patients. Previous studies found that patients with esophageal and gastroesophageal junction cancer could easily use and accept STRONG. No major safety concerns arose, indicating the program's safety. Participants used the program, which includes consultations and a Fitbit app, without significant issues. Although specific side effects were not detailed, current evidence suggests the program is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Guidance Program for gastroesophageal cancer because it takes a personalized and tech-savvy approach to dietary management. Unlike standard care, which typically involves general dietary advice, this program offers participants biweekly consultations with a dietitian and continuous support through a smartphone app and wearable device. By allowing patients to track their food intake daily and receive tailored dietary recommendations, this program aims to address individual dietary challenges more effectively. This level of personalization and constant monitoring is a game-changer, potentially leading to better nutritional outcomes and overall well-being for patients.

What evidence suggests that the STRONG Program is effective for reducing malnutrition in gastroesophageal cancer patients?

Research shows that the STRONG program, available to participants in this trial, may help reduce malnutrition in patients with gastroesophageal cancer. Earlier studies found it practical and helpful for patients. The program offers nutritional advice and regular check-ins with a dietitian to help patients manage their diets more effectively. By using a smartphone app and a Fitbit, patients can monitor their food intake and receive personalized tips. Early results suggest this method could improve nutrition and quality of life for participants. Although more information is needed, the initial findings are promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Jose M Pimiento, MD

Principal Investigator

Moffitt Cancer Center

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with gastroesophageal cancer who may be at risk of malnutrition. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I plan to start chemo or radiation and have surgery at Moffitt.

I can speak and read in English or Spanish.

Participants must be able to provide informed consent

Exclusion Criteria

Use of feeding tubes at the time of study enrollment

I do not have a severe mental or neurological condition that would prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

STRONG Intervention

Participants receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. They will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device, complete 6 questionnaires, and have the option to participate in a voluntary interview.

12 weeks

Biweekly visits (in-person or virtual)

Usual Care Intervention

Participants are referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, treatment adherence, and nutritional status.

Up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

• Support Through Remote Observation and Nutrition Guidance Program

Trial Overview The STRONG intervention, which includes surveys on health and social factors, consultations with dietitians, referrals as needed, and monitoring activity levels using a Fitbit device, is being tested against usual care practices.

How Is the Trial Designed?

Group I: STRONG Intervention Experimental Treatment 4 Interventions

Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.

Group II: Usual Care Intervention Active Control 3 Interventions

Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

This study will assess the prevalence of malnutrition in patients with upper gastrointestinal cancers at the time of surgery, using subjective global assessment, across 27 Australian hospitals.

It aims to evaluate the types and frequency of nutritional interventions provided perioperatively, and how these relate to malnutrition prevalence, which could help improve patient outcomes in surgical oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Outcomes of patients Undergoing Resection for upper gastroIntestinal cancer in AuStralian Hospitals (NOURISH): protocol for a multicentre point prevalence study. Deftereos, I., Yeung, JMC., Carter, VM., et al.[2021]

In a study of 502 Chinese patients with esophageal squamous cell carcinoma (ESCC), baseline nutritional status, particularly measured by Body Mass Index (BMI), was found to significantly predict overall survival (OS), with lower BMI correlating with poorer outcomes.

Patients with a BMI less than 18.5 had a median OS of only 19.2 months, compared to 43.2 months for those with a BMI between 18.5-24.9 and 51.6 months for those with a BMI over 24.9, highlighting the importance of nutritional evaluation in treatment planning for ESCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the prognostic values of various nutritional parameters in patients with esophageal squamous cell carcinoma from Southern China. Sun, P., Zhang, F., Chen, C., et al.[2021]

In a study of 170 patients with head and neck or esophageal cancers, adherence to evidence-based guidelines for nutrition care was good for initial screenings and assessments but poor for timely post-operative nutrition support, highlighting significant gaps in practice.

Improving nutrition care for cancer patients may require high-quality research to address these gaps and the development of practical implementation guidance to help clinicians better support patients throughout their treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Evidence-Based Guidelines into Practice-Are We Getting It Right? A Multi-Centre Prospective International Audit of Nutrition Care in Patients with Foregut Tumors (INFORM). Findlay, M., Bauer, JD., Dhaliwal, R., et al.[2023]

Human papillomavirus (HPV) infection may lead to esophageal cancer over several decades, highlighting the importance of early detection and monitoring for those infected.

A multidisciplinary treatment approach, including surgery, radiation, chemotherapy, and nutritional support, significantly improves survival and quality of life for esophageal cancer patients, particularly the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Operative indications and treatment in elderly patients with esophageal cancer]. Ogoshi, S., Iwasa, Y., Iwasa, M.[2011]

A study of 80 gastric cancer patients showed that enteral nutrition support combined with a multiform Internet education mode significantly improved nutritional knowledge, body weight, and other nutritional indexes compared to traditional education methods.

Patients receiving the Internet-based education also reported better quality of life and reduced negative emotions, indicating that this approach not only enhances nutritional support but also helps in managing the psychological aspects of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Enteral Nutrition Support Based on Multiform Internet Education Mode on Perioperative Nutritional Indexes and Quality of Life of Patients with Gastric Cancer. He, H., Yu, F., Wang, F., et al.[2023]

In a study of 90 patients undergoing postoperative chemotherapy for esophageal cancer, those receiving sequential early enteral nutrition (ESEN) showed significantly improved nutritional markers, including higher levels of protein, albumin, and hemoglobin compared to those receiving non-sequential enteral nutrition.

Patients in the ESEN group experienced better recovery outcomes, including reduced exhaustion, faster incision healing, shorter hospital stays, and improved quality of life scores, indicating that this nutritional approach is beneficial for post-surgery recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sequential vs. non-sequential early enteral nutrition therapy on nutritional status, recovery, and quality of life of patients with esophageal cancer. Song, HX., Wei, SH., An, GH., et al.[2023]

Malnutrition is a significant issue for over half of patients with digestive cancers, negatively impacting their survival, quality of life, and treatment outcomes, highlighting the need for early detection and intervention.

The French intergroup guidelines emphasize the importance of integrating nutritional support and physical activity into the overall management of digestive cancers at all stages of the disease, from diagnosis through palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity: French intergroup clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, AFC, SFP-APA, SFNCM, AFSOS). Neuzillet, C., Anota, A., Foucaut, AM., et al.[2021]

In a study of 200 patients undergoing upper gastrointestinal cancer surgeries, only 34.9% adhered to the ESPEN guidelines for postoperative nutrition support, indicating a significant gap in clinical practice.

Patients who received inadequate nutritional support, particularly those undergoing pancreatic and gastric surgeries, experienced longer hospital stays and more complications, highlighting the importance of timely nutritional intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to ESPEN guidelines and associations with postoperative outcomes in upper gastrointestinal cancer resection: results from the multi-centre NOURISH point prevalence study. Deftereos, I., Yeung, JM., Arslan, J., et al.[2022]

A review of 26 nutrition management guidelines for upper gastrointestinal cancer patients revealed that while most guidelines were rigorous, only 23% were up-to-date, indicating a need for current evidence-based recommendations.

Key areas lacking strong evidence include immunonutrition, pancreatic enzyme replacement therapy, and management of complications after discharge, highlighting the necessity for further research in these domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Evidence-Based Practice Guidelines Into a Summary of Recommendations for the Nutrition Management of Upper Gastrointestinal Cancers. Lu, Y., Carey, S.[2019]

Esophageal cancer patients undergoing radiotherapy are at a high risk of malnutrition, which can worsen treatment side effects and reduce the effectiveness of the therapy, highlighting the need for timely nutritional interventions.

An expert consensus conference established guidelines for enteral nutrition in these patients, covering aspects like nutritional screening, counseling, and evaluation, to improve their overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral nutrition in esophageal cancer patients treated with radiotherapy: a Chinese expert consensus 2018. Lyu, J., Li, T., Xie, C., et al.[2019]

In a study of 245 patients with oesophageal cancer, preoperative support from dietitians did not lead to significant differences in postoperative weight loss or nutrition impact symptoms one year after surgery.

Patient satisfaction with dietitian support also showed no significant association with weight loss or nutrition impact symptoms, suggesting that existing support systems may already be effectively addressing malnutrition in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of dietitian support in improving weight loss and nutrition impact symptoms after oesophageal cancer surgery. Anandavadivelan, P., Wikman, A., Mälberg, K., et al.[2021]

The NOA project successfully increased the integration of nutritional evaluations in cancer care plans across three hospitals in Andalusia, leading to more comprehensive support for patients over a six-month period.

Enhanced participation of the Nutrition Support Team in tumor boards, especially for head and neck and oesophagogastric cancers, has improved the management of malnutrition in cancer patients, demonstrating the importance of nutrition in oncological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Nutritional Interventions in the Care Plan for Cancer Patients: The NOA Project. García-Luna, PP., Rabat Restrepo, JM., Muñoz-Ayllón, M., et al.[2023]

The implementation of a standardized perioperative nutrition pathway for patients undergoing upper gastrointestinal cancer surgery significantly improved access to dietetic care, with preoperative dietetic intervention rates increasing from 55% to 100%.

The study demonstrated high adherence to the nutrition pathway (over 70% for all stages), suggesting that a larger trial is feasible, and it may lead to better nutritional outcomes and potentially reduce hospital admissions and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a standardised perioperative nutrition care pathway in upper gastrointestinal cancer surgery: A multisite pilot study. Deftereos, I., Hitch, D., Butzkueven, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06497569

Study Details | NCT06497569 | Support Through Remote ... The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.

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. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000188

A study protocol for a pilot randomized controlled trial We will collect preliminary data on outcomes that may be associated with the intervention including malnutrition, quality of life, treatment outcomes, and ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05484

Support Through Remote Observation and Nutrition ... This clinical trial tests whether the STRONG program can help manage malnutrition and improve quality-of-life in patients with gastroesophageal cancer who ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05438940

Support Through Remote Observation and Nutrition ... The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) ...

6. trialx.com trialx.com/clinical-trials/listings/299348/support-through-remote-observation-and-nutrition-guidance-program-for-individuals-with-gastroesophageal-cancer/

Support Through Remote Observation and Nutrition ... The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal ...