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

NCT05203627 | Active Not Recruiting DMC

• 3 other identifiers: 19220NCI-2021-12909P30CA033572
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Carcinoma; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 6 months

Study Arms (2)

Arm I (telehealth session, guidebook)

EXPERIMENTAL

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

Other: Questionnaire Administration; Other: Telemedicine Visit

Arm II (standard nutritional support)

ACTIVE COMPARATOR

Patients receive standard nutritional support.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard nutritional support

Also known as: standard of care, standard therapy

Arm II (standard nutritional support)

Questionnaire Administration OTHER

Ancillary studies

Arm I (telehealth session, guidebook); Arm II (standard nutritional support)

Telemedicine Visit OTHER

Receive telehealth sessions

Arm I (telehealth session, guidebook)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Jae Y Kim

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 24, 2022
• Study Start: January 21, 2020
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)