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
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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ACTIVE_NOT_RECRUITING
NA
53 participants
INTERVENTIONAL
2020-01-21
2026-06-15
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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.
Questionnaire Administration
Ancillary studies
Telemedicine Visit
Receive telehealth sessions
Arm II (standard nutritional support)
Patients receive standard nutritional support.
Best Practice
Receive standard nutritional support
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive standard nutritional support
Questionnaire Administration
Ancillary studies
Telemedicine Visit
Receive telehealth sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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NCI-2021-12909
Identifier Type: REGISTRY
Identifier Source: secondary_id
19220
Identifier Type: OTHER
Identifier Source: secondary_id
19220
Identifier Type: -
Identifier Source: org_study_id
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