An interventional study of Best Practice and Questionnaire Administration in Gastric Carcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by City of Hope Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 53 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.
Other: Questionnaire Administration · Other: Telemedicine Visit
Patients receive standard nutritional support.
Other: Best Practice · Other: Questionnaire Administration
Receive standard nutritional support
Also known as: standard of care, standard therapy
Ancillary studies
Receive telehealth sessions
Feasibility of the Telehealth Intervention - Percent Participation
Feasibility of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention will be measured by the percentage of patients who agree to participate.
Time frame: Up to 6 months
Feasibility of the Telehealth Intervention - Percent Completion
Feasibility of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention will be measured by the percentage of patients who completes two sessions.
Time frame: Up to 6 months
Retention of the TIMES intervention
Measured by the percentage of patients who complete a majority of the intervention (at least 2 sessions).
Time frame: Up to 6 months
Satisfaction of the TIMES intervention
Measured by the percentage of patients who report satisfaction with the intervention (through structured exit interviews). Satisfaction and engagement will be assessed through the exit interview via qualitative data, content analysis approach.
Time frame: Up to 6 months
Patient reported outcomes - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ30):
EORTC-QLQ30 will be assessed with a 30-item instrument for QOL assessment, with subscales/items for function, global health, general symptoms (fatigue, pain, nausea, and vomiting), and financial toxicity.
Time frame: Up to 6 months
Patient reported outcomes - EORTC-Oesophago-Gastric Cancer Module
(EORTC-OG25) will be assessed with a 25-item measure for esophagogastric cancer-specific symptoms and emotional well-being.
Time frame: Up to 6 months
Patient reported outcomes - Patient Activation Measure (PAM)
Patient Activation Measure (PAM) will be assessed by using a Guttman-like scale that reflects a patient's level of engagement and empowerment in their healthcare.
Time frame: Up to 6 months
Patient reported outcomes - General Self-Efficacy Scale
A General Self-Efficacy Scale developed by Jerusalem and colleagues contains 10 items that assess perceived confidence in self-management. Items are rated on a 4-point Likert scale.
Time frame: Up to 6 months
Patient reported outcomes - The Post-Gastrectomy Nutrition Questionnaire
The Post-Gastrectomy Nutrition Questionnaire is a tool developed by the investigators to assess patient knowledge about diet and nutrition after surgery for GE cancer. Each item addresses specific content discussed in the telehealth sessions to assess changes in knowledge. Scoring is based on the number of questions answered correctly.
Time frame: Up to 6 months
Objective measures of patient nutrition - Weight
Weight will be recorded at baseline and 6 months to examine the preliminary efficacy of the intervention on objective measures of patient nutrition. Weight will be measured by kg.
Time frame: Up to 6 months
Objective measures of patient nutrition - Body Mass Index (BMI)
Body Mass Index will be calculated and recorded by dividing weight in Kg by height in m\^2 at baseline and 6 months to examine the preliminary efficacy of the intervention on objective measures of patient nutrition.
Time frame: Up to 6 months
Objective measures of patient nutrition - Albumin levels
Serum albumin levels collected as routine follow-up care will be recorded at baseline and 6 months to examine the preliminary efficacy of the intervention on objective measures of patient nutrition. Albumin level will be measured g/dl.
Time frame: Up to 6 months
Objective measures of patient nutrition - Skeletal mass Index
Sarcopenia/skeletal muscle mass will be calculated at baseline and 6 months through CT scans performed as part of routine follow-up for gastroesophageal cancer include cross-sectional images at the level of the third lumbar vertebra (L3). The cross-sectional area of skeletal muscle mass in this region has been found in multiple studies to correlate with total body skeletal muscle mass. Skeletal muscle mass will be quantified using well described techniques applying a predefined Hounsfield unit (HU) threshold of -25 to 150 HU for skeletal muscle mass. Muscle boundaries will be corrected manually when necessary to obtain cross-sectional areas (cm2) for skeletal muscle. Skeletal muscle index (SMI, cm2/m2) is defined as the cross-sectional area of muscle at the L3 level normalized for BMI.
Time frame: Up to 6 months
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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