- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05203627
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (telehealth session, guidebook)
Patients receive 4 telehealth sessions over 1 hour each over 4 months.
Patients also receive an intervention guidebook.
|
Ancillary studies
Receive telehealth sessions
|
Active Comparator: Arm II (standard nutritional support)
Patients receive standard nutritional support.
|
Ancillary studies
Receive standard nutritional support
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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).
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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. |
Up to 6 months
|
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. |
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jae Y Kim, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19220 (Other Identifier: City of Hope Comprehensive Cancer Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2021-12909 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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