Gastric CarcinomaNCT05203627
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
A study testing Best Practice, Questionnaire Administration and Telemedicine Visit in people with Gastric Carcinoma and Gastroesophageal Junction Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Best Practice, Questionnaire Administration and Telemedicine Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 4 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
About this study
Official title: Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Best Practice, Questionnaire Administration, Telemedicine Visit
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard nutritional support
Questionnaire AdministrationOther
Ancillary studies
Telemedicine VisitOther
Receive telehealth sessions
| Study group | Role | What they receive |
|---|---|---|
| Arm I (telehealth session, guidebook) | Experimental | Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook. Receives: Other: Questionnaire Administration; Other: Telemedicine Visit |
| Arm II (standard nutritional support) | Active comparator | Patients receive standard nutritional support. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start21 Jan 2020
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jae Y Kim, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203627
- Sponsor's protocol ID
- 19220
- Other IDs
- NCI-2021-12909, 19220, P30CA033572
- Status last verified
- Nov 2026
- First submitted
- 6 Dec 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT05203627
- Acronym / sponsor ID
- 19220
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (telehealth session, guidebook) | Experimental | Other: Questionnaire Administration, Other: Telemedicine VisitPatients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook. |
| Arm II (standard nutritional support) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive standard nutritional support. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard nutritional support | Other | Arm II (standard nutritional support) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (telehealth session, guidebook), Arm II (standard nutritional support) |
| Telemedicine VisitReceive telehealth sessions | Other | Arm I (telehealth session, guidebook) |
Primary outcome
Feasibility of the Telehealth Intervention - Percent Participation
Time frame: Up to 6 months
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.
Feasibility of the Telehealth Intervention - Percent Completion
Time frame: Up to 6 months
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.
Retention of the TIMES intervention
Time frame: Up to 6 months
Measured by the percentage of patients who complete a majority of the intervention (at least 2 sessions).
Satisfaction of the TIMES intervention
Time frame: Up to 6 months
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.
Patient reported outcomes - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ30):
Time frame: Up to 6 months
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.
Patient reported outcomes - EORTC-Oesophago-Gastric Cancer Module
Time frame: Up to 6 months
(EORTC-OG25) will be assessed with a 25-item measure for esophagogastric cancer-specific symptoms and emotional well-being.
Patient reported outcomes - Patient Activation Measure (PAM)
Time frame: Up to 6 months
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.
Patient reported outcomes - General Self-Efficacy Scale
Time frame: Up to 6 months
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.
Patient reported outcomes - The Post-Gastrectomy Nutrition Questionnaire
Time frame: Up to 6 months
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.
Objective measures of patient nutrition - Weight
Time frame: Up to 6 months
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.
Objective measures of patient nutrition - Body Mass Index (BMI)
Time frame: Up to 6 months
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.
Objective measures of patient nutrition - Albumin levels
Time frame: Up to 6 months
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.
Objective measures of patient nutrition - Skeletal mass Index
Time frame: Up to 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Y Kim principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Questionnaire Administration and Telemedicine Visit in people with Gastric Carcinoma and Gastroesophageal Junction Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Telehealth Intervention - Percent Participation (time frame: Up to 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.