NCT04985084

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

Completed NA Last updated 30 April 2024

What this trial tests

NA trial testing The intervention group in Stomach Neoplasms in 35 participants. Completed in 15 August 2022.

Timeline

12 January 2022

Primary endpoint
15 June 2022

15 August 2022

Quick facts

Lead sponsor	The Hong Kong Polytechnic University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	35
Start date	12 January 2022
Primary completion	15 June 2022
Estimated completion	15 August 2022
Sites	1 location across China

Drugs / interventions tested

• The intervention group
• Usual care

Conditions studied

• Stomach Neoplasms — all drugs for Stomach Neoplasms →
• Cancer Survivors — all drugs for Cancer Survivors →

Sponsor

The Hong Kong Polytechnic University

Who can join

Adults 18 to 75, any sex, with Stomach Neoplasms or Cancer Survivors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development of a nurse-led, evidence-based, and theory-informed dietary intervention to modify multiple unhealthy dietary behaviors in gastric cancer survivors.
   Gan T, Cheng H, Tse MYM, He N. · · 2025 · PMID 40611825 · DOI 10.1016/j.apjon.2025.100739