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

53 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Diet Support Intervention, Telemedicine Visit, Temodar, Temodal, TMZ, SCH 52365, NSC 362856 for stomach cancer post-surgery?

Research shows that personalized nutritional and educational interventions can improve nutritional status and treatment compliance in gastric cancer patients undergoing chemotherapy. Additionally, post-discharge nutritional supplements with dietary advice have been shown to improve nutritional outcomes and quality of life in patients at nutritional risk after surgery for gastric cancer. ^{1 2 3 4 5}

Is telehealth diet management safe for stomach cancer post-surgery?

The studies reviewed focus on the effectiveness of nutritional interventions after stomach cancer surgery, but they do not provide specific safety data for telehealth diet management. However, these interventions generally aim to improve nutrition and quality of life, suggesting they are designed with patient safety in mind. ^{1 2 5 6 7}

How is the Telehealth Diet Management treatment for stomach cancer post-surgery different from other treatments?

This treatment is unique because it uses telehealth (remote healthcare services) to provide personalized diet management for stomach cancer patients after surgery, focusing on early and intensive nutrition care to improve quality of life and weight preservation. It leverages digital tools like mobile applications and wearable devices to deliver tailored interventions, which is a novel approach compared to traditional in-person dietetic services. ^{1 2 8 9 10}

What is the purpose of this trial?

This clinical trial test whether taking part in a diet support intervention will help with patients nutrition and quality of life after surgery for esophagus or stomach cancer. The information learned by doing this research study may help patients get more information and/or support on eating after esophagus and stomach cancer surgery.

Research Team

Jae Y Kim

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Effectiveness of a personalized digital exercise and nutrition-based rehab program for patients with gastric cancer after surgery: Study protocol for a randomized controlled trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

The effectiveness of health education based on the 5Ts for teach-back on oral nutritional supplements compliance of post-discharge patients after surgery for gastric cancer: a randomized controlled trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary counseling on nutritional status and quality of life in post-discharge patients after surgery for gastric cancer: A randomized clinical trial. [2023]

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

Beneficial Effect of Educational and Nutritional Intervention on the Nutritional Status and Compliance of Gastric Cancer Patients Undergoing Chemotherapy: A Randomized Trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

A process and mechanism of action evaluation of the effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: a study protocol. [2019]

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

Use of Telehealth Among Cancer Survivors: A Scoping Review. [2023]

10. 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]