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

Primary Purpose

Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Questionnaire Administration
Telemedicine Visit
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (telehealth session, guidebook)

Arm II (standard nutritional support)

Arm Description

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

Patients receive standard nutritional support.

Outcomes

Primary Outcome Measures

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.
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.
Retention of the TIMES intervention
Measured by the percentage of patients who complete a majority of the intervention (at least 2 sessions).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2021
Last Updated
August 3, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05203627
Brief Title
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
Official Title
Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 stomach cancer surgery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (telehealth session, guidebook)
Arm Type
Experimental
Arm Description
Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.
Arm Title
Arm II (standard nutritional support)
Arm Type
Active Comparator
Arm Description
Patients receive standard nutritional support.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard nutritional support
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Telemedicine Visit
Intervention Description
Receive telehealth sessions
Primary Outcome Measure Information:
Title
Feasibility of the Telehealth Intervention - Percent Participation
Description
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
Title
Feasibility of the Telehealth Intervention - Percent Completion
Description
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
Title
Retention of the TIMES intervention
Description
Measured by the percentage of patients who complete a majority of the intervention (at least 2 sessions).
Time Frame
Up to 6 months
Title
Satisfaction of the TIMES intervention
Description
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
Title
Patient reported outcomes - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ30):
Description
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
Title
Patient reported outcomes - EORTC-Oesophago-Gastric Cancer Module
Description
(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
Title
Patient reported outcomes - Patient Activation Measure (PAM)
Description
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
Title
Patient reported outcomes - General Self-Efficacy Scale
Description
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
Title
Patient reported outcomes - The Post-Gastrectomy Nutrition Questionnaire
Description
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
Title
Objective measures of patient nutrition - Weight
Description
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
Title
Objective measures of patient nutrition - Body Mass Index (BMI)
Description
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
Title
Objective measures of patient nutrition - Albumin levels
Description
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
Title
Objective measures of patient nutrition - Skeletal mass Index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Y Kim
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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