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

Primary outcomes

1. 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.

2. 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.

3. 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).

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.