Telehealth Diet Management for Stomach Cancer Post-Surgery

Overseen By Jae Y Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Non-compliance, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a diet support program can improve nutrition and quality of life after surgery for stomach or esophagus cancer. It compares standard nutritional support with a more involved approach that includes four telehealth sessions (referred to as Telemedicine Visits) and a guidebook. Individuals who have had surgery for gastric or gastroesophageal cancer and have resumed eating within the last month may qualify, provided they can participate in telehealth sessions and understand English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgery recovery 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 coordinator or your doctor.

What prior data suggests that this diet support intervention and telemedicine visit are safe?

Research has shown that using telehealth for follow-up visits after cancer surgeries is generally safe. Studies have found that patients often find telehealth easy to use and are satisfied with it. Reports also indicate that patients usually adhere to the telehealth program as instructed.

For the diet support program, which includes telehealth sessions and a guidebook, no major safety issues have been reported. Current evidence suggests that patients manage this approach well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a novel approach to diet management after stomach cancer surgery. Unlike traditional nutritional support, which typically involves in-person visits and generic guidelines, this trial uses telehealth technology to deliver personalized dietary guidance. Patients receive four telehealth sessions and an intervention guidebook, which allows for more flexible and continuous support from the comfort of their homes. This method is particularly promising because it has the potential to improve patient compliance and outcomes by making dietary management more accessible and personalized.

What evidence suggests that this trial's treatments could be effective for stomach cancer post-surgery?

Research has shown that telehealth diet support can help manage eating problems after stomach cancer surgery. In this trial, participants in Arm I will receive telehealth sessions and an intervention guidebook as part of their diet support. A small study demonstrated that a telehealth program led by a nutritionist helped patients address eating issues after surgery for gastroesophageal cancer. Patients found this telehealth approach easy to use and satisfying. Meanwhile, Arm II participants will receive standard nutritional support. Another study found that 49% of people who survived upper gastrointestinal cancer still had eating restrictions a year after surgery, highlighting the need for effective support post-surgery. These findings suggest telehealth could be a useful tool for improving nutrition and quality of life after surgery. ^{3 5 6 7 8}

Who Is on the Research Team?

Jae Y Kim

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 21 who've had surgery to remove stomach or gastroesophageal junction cancer and are starting to eat orally again. Participants must understand English or Spanish, be able to give informed consent, and participate in telehealth sessions. Those unable to follow the study's safety requirements can't join.

Inclusion Criteria

I can understand English or Spanish.

I can join telehealth sessions.

I am 21 years old or older.

Exclusion Criteria

Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.

16 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Diet Support Intervention
• Telemedicine Visit

Trial Overview The trial examines if a diet support program delivered via telehealth improves nutrition and life quality after esophagus or stomach cancer surgery. It involves questionnaires, virtual visits, and follows best practices for dietary management post-surgery.

How Is the Trial Designed?

Group I: Arm I (telehealth session, guidebook) Experimental Treatment 2 Interventions

Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.

Group II: Arm II (standard nutritional support) Active Control 2 Interventions

Patients receive standard nutritional support.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

Telehealth is a promising and feasible option for supporting cancer survivors, particularly in enhancing their physical and mental quality of life during the extended survival phase (1 to 3 years post-diagnosis).

However, there is a notable lack of telehealth interventions specifically designed for long-term survivors (over 5 years post-diagnosis), highlighting a gap in care that needs to be addressed, especially regarding their social and spiritual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telehealth Among Cancer Survivors: A Scoping Review. Irurita-Morales, P., Soto-Ruiz, N., Martín-Rodríguez, LS., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38164022/

Pilot study of a telehealth intervention for personalized self ... We performed a randomized pilot study of a nutritionist-led telehealth intervention for the self-management of eating after gastroesophageal cancer surgery.

2. clinicaltrial.be clinicaltrial.be/en/details/882?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Telehealth for the Self-Management of Dietary Quality of... Assess the feasibility, retention, and satisfaction of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jso.27568

Pilot study of a telehealth intervention for personalized self ... This pilot study demonstrated the feasibility and acceptability of a telehealth intervention for self-management of eating symptoms after ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9179413/

Telehealth Delivery of a Multi-Disciplinary Rehabilitation ... Nutritional compromise in UGI cancer survivors is frequently reported, with eating restrictions are observed in 49% at 1 year post-surgery and malabsorption in ...

5. researchgate.net researchgate.net/publication/377100862_Pilot_study_of_a_telehealth_intervention_for_personalized_self-management_for_eating_symptoms_after_gastroesophageal_cancer_surgery

Pilot study of a telehealth intervention for personalized self ... Conclusions This pilot study demonstrated the feasibility and acceptability of a telehealth intervention for self‐management of eating symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9458545/

The safety and acceptability of using telehealth for follow-up of ... This review aims to examine the feasibility, safety, and patient satisfaction with virtual follow-up appointments after cancer operations.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818102

Digital Health Interventions and Patient Safety in ... Overall, the studies reported high levels of patient compliance and satisfaction with telehealth technologies in perioperative management.

8. 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.