Development and Testing of a Social Cognitive Theory-based Dietary Behavioral Intervention in Gastric Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a Social Cognitive Theory (SCT)-based dietary behavioral intervention for gastric cancer survivors, and explore the feasibility, acceptability, and preliminary effectiveness of delivering this intervention. This study includes two phases: intervention development in phase 1 and a pilot randomized controlled trial (RCT) in phase 2. During phase 1, the initial intervention protocol has been developed based on the SCT and literature review, which was further refined and/or enriched based on evidences from a qualitative descriptive study and an expert consultation. The qualitative descriptive study has been conducted from July to November 2021, and the expert consultation has been conducted from December 2021 to January 2022. For the qualitative descriptive study, purposive sampling was used to select eligible participants in patients who had a gastrectomy within two years from a tertiary hospital in Wuhan city, China. Three focus group interviews were performed with 13 participants via WeChat. Interviews were audio-recorded, transcribed verbatim, and analyzed using conventional qualitative content analysis. Data collection and analysis proceeded simultaneously until data saturation was reached. For the expert consultation, six experts majoring in nursing, digestive oncology, or nutrition were invited to assess the content validity of the intervention protocol. Data analysis of the qualitative descriptive study and the expert consultation is ongoing. During phase 2, the pilot RCT for testing the feasibility, acceptability, and preliminary effectiveness of the proposed intervention is started. All participants are recruited through convenience sampling from a tertiary hospital in Wuhan city, China. Sample size of the pilot RCT is proposed to be 72. After randomization, the participants are assigned to one of two groups, either the intervention group, which receive a 4-week dietary behavioral intervention; or the control group, which receive usual care only. The 4-week dietary behavioral intervention targets six dietary behaviors related to gastric cancer and is delivered by a registered nurse who has received around 32 hours of nutrition training. The intervention includes one session of face-to-face education and three sessions of telephone counselling; all sessions are individual based. The usual care is general dietary advice provided by the ward nurses before discharge. The general dietary advice is provided orally and printed in the discharge plan. The primary outcomes are feasibility and acceptability. The secondary outcomes include dietary consumption, quality of life, and self-efficacy. Outcome measurements are conducted at baseline (before randomization), and week 5 (after intervention). Generalized estimating equation model analyses will be conducted to examine group-by-time interaction effects.

Official Title
-----------------
Development and Testing of a Social Cognitive Theory-based Dietary Behavioral Intervention in Gastric Cancer Survivors: Protocol for a Pilot Randomized Controlled Trial

Conditions
-----------------
Stomach Neoplasms, Cancer Survivors

Intervention / Treatment
-----------------
* Behavioral: The intervention group
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged 18 years or above； A confirmed diagnosis of gastric cancer (stage I-III)； Completed primary cancer treatments including surgery, and/or chemotherapy， and/or radiotherapy； Currently free of cancer； Able to read, write and speak Mandarin. Exclusion Criteria: Unable to eat orally； With poor performance status as determined by the Eastern Cooperative Oncology Group (ECOG) scores ≥ 2; With poor cognitive status as determined by the Montreal Cognitive Assessment 5 minute Test <11; Taking part in other dietary interventions or under regular follow-up by a dietitian.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>A 4-week dietary behavioral intervention provided by a registered nurse who has received nutrition training. | Behavioral: The intervention group<br>* The intervention will last for four weeks and target six dietary behaviors related to gastric cancer. The intervention components include one session of face-to-face education prior to discharge and three sessions of telephone counselling after discharge. The face-to-face education will last for 20 to 30 minutes and each session of telephone counselling will last for 10 to 20 minutes. All the interventional sessions are individual based.<br>|
| Other: Usual care<br>General dietary advice provided by the ward nurses. | Other: Usual care<br>* General dietary advice provided as routine by the ward nurses before discharge from the hospital.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility outcome: time to complete the recruitment | Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment. | Immediately after completion of the intervention (T1) | 
| Feasibility outcome: eligibility rate | Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened. | Immediately after completion of the intervention (T1) | 
| Feasibility outcome: recruitment rate | Recruitment rate will be calculated by dividing the number of eligible participants who have consented and been randomized by the total number of eligible participants. | Immediately after completion of the intervention (T1) | 
| Feasibility outcome: retention rate | Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants randomized. | Immediately after completion of the intervention (T1) | 
| Feasibility outcome: attendance rate | Attendance rate will be calculated by dividing the number of participants completed 4 interventional sessions by the number of participants assigned to the intervention group. | Immediately after completion of the intervention (T1) | 
| Acceptability outcome: participants' satisfaction and perspectives of the intervention | Participants' satisfaction and perspectives of the intervention will be assessed using a self-developed questionnaire designed for the study. | Immediately after completion of the intervention (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary consumption | Dietary consumption will be measured through telephone-assisted 24-hour dietary recall in three non-consecutive days (E.g., two workdays and one day during the weekend) | Baseline before randomization (T0); Immediately after completion of the intervention (T1) | 
| Health-related quality of life | Health-related quality of life will be assessed using the 46-item Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) questionnaire. Each item is scored from 0 to 4 and the total score range from 0 to 184, with a higher score indicating better quality of life. | Baseline before randomization (T0); Immediately after completion of the intervention (T1) | 
| General self-efficacy | General self-efficacy will be assessed using the 10-item general self-efficacy scale. Each item is scored from 0 to 4 and the total score range from 0 to 40, with a higher score indicating higher general self-efficacy. | Baseline before randomization (T0); Immediately after completion of the intervention (T1) | 
| Dietary behavior self-efficacy | Dietary behavior self-efficacy will be assessed using a self-developed 6-item dietary behavior self-efficacy scale. Each item is scored from 0 to 4 and the total score range from 0 to 24, with a higher score indicating higher dietary behavior self-efficacy. | Baseline before randomization (T0); Immediately after completion of the intervention (T1) |