Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery

NCT ID: NCT05203627

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2026-06-15

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. Assess the feasibility, retention, and satisfaction of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention as measured by the percentage of patients who a) agree to participate; b) complete a majority of the intervention (at least 2 sessions); and c) report satisfaction with the intervention (through structured exit interviews).

II. Assess the preliminary efficacy of TIMES for patient reported outcomes for quality of life (QOL), dietary symptoms, and self-management.

III. Assess the preliminary efficacy of TIMES for objective measures of patient nutrition.

OUTLINE: Patients are randomized in to 1 of 2 arms.

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

ARM II: Patients receive standard nutritional support.

After completion of study, patients are followed up for 6 months.

Conditions

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Gastric Carcinoma Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Arm I (telehealth session, guidebook)

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

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telemedicine Visit

Intervention Type OTHER

Receive telehealth sessions

Arm II (standard nutritional support)

Patients receive standard nutritional support.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard nutritional support

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard nutritional support

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Telemedicine Visit

Receive telehealth sessions

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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Inclusion Criteria

* The ability to understand English or Spanish.
* Undergone curative intent surgery for gastric or gastroesophageal (GE) junction cancer.
* Began oral intake within the past month.
* Aged 21 years and older.
* Able to participate in telehealth sessions.
* This study will be conducted in patients aged 21 years or older who have undergone curative intent surgery for gastric or GE junction cancer.
* Age criterion for this trial is based on the National Institute of Health (NIH')s age criteria, which defines an adult as individuals aged 21 years and over. There are no restrictions related to performance status or life expectancy.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Y Kim

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-12909

Identifier Type: REGISTRY

Identifier Source: secondary_id

19220

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19220

Identifier Type: -

Identifier Source: org_study_id

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