Stomach NeoplasmsNCT04985084
Development and Testing of a Social Cognitive Theory-based Dietary Behavioral Intervention in Gastric Cancer Survivors
A study testing The intervention group in people with Stomach Neoplasms and Cancer Survivors, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms, Cancer Survivors
- What is being tested?
- The intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Stomach Neoplasms, Cancer Survivors
- Being tested
- The intervention group, Usual care
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention groupBehavioural
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.
Usual careOther
General dietary advice provided as routine by the ward nurses before discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | A 4-week dietary behavioral intervention provided by a registered nurse who has received nutrition training. Receives: Behavioral: The intervention group |
| Usual care | Other | General dietary advice provided by the ward nurses. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after completion of the intervention (T1)
Secondary outcomes (4)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline before randomization (T0); Immediately after completion of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start12 Jan 2022
- Primary completion15 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr CHENG Huilin, The Hong Kong Polytechnic University
- Investigators
- Huilin Cheng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985084
- Sponsor's protocol ID
- 02
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gan T, Cheng H, Tse MYM, He N. Development of a nurse-led, evidence-based, and theory-informed dietary intervention to modify multiple unhealthy dietary behaviors in gastric cancer survivors. Asia Pac J Oncol Nurs. 2025 Jun 9;12:100739. doi: 10.1016/j.apjon.2025.100739. eCollection 2025 Dec.
PubMed 40611825
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04985084
- Acronym / sponsor ID
- 02
- Conditions
- Stomach Neoplasms, Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: The intervention groupA 4-week dietary behavioral intervention provided by a registered nurse who has received nutrition training. |
| Usual care | Other | Other: Usual careGeneral dietary advice provided by the ward nurses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention groupThe 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. | Behavioural | The intervention group |
| Usual careGeneral dietary advice provided as routine by the ward nurses before discharge from the hospital. | Other | Usual care |
Primary outcome
Feasibility outcome: time to complete the recruitment
Time frame: Immediately after completion of the intervention (T1)
Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment.
Feasibility outcome: eligibility rate
Time frame: Immediately after completion of the intervention (T1)
Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.
Feasibility outcome: recruitment rate
Time frame: Immediately after completion of the intervention (T1)
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.
Feasibility outcome: retention rate
Time frame: Immediately after completion of the intervention (T1)
Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants randomized.
Feasibility outcome: attendance rate
Time frame: Immediately after completion of the intervention (T1)
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.
Acceptability outcome: participants' satisfaction and perspectives of the intervention
Time frame: Immediately after completion of the intervention (T1)
Participants' satisfaction and perspectives of the intervention will be assessed using a self-developed questionnaire designed for the study.
4 secondary outcomes
Dietary consumption
Time frame: Baseline before randomization (T0); Immediately after completion of the intervention (T1)
Health-related quality of life
Time frame: Baseline before randomization (T0); Immediately after completion of the intervention (T1)
General self-efficacy
Time frame: Baseline before randomization (T0); Immediately after completion of the intervention (T1)
Dietary behavior self-efficacy
Time frame: Baseline before randomization (T0); Immediately after completion of the intervention (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 40611825Gan T, Cheng H, Tse MYM, He N. Development of a nurse-led, evidence-based, and theory-informed dietary intervention to modify multiple unhealthy dietary behaviors in gastric cancer survivors. Asia Pac J Oncol Nurs. 2025 Jun 9;12:100739. doi: 10.1016/j.apjon.2025.100739. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huilin Cheng, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention group in people with Stomach Neoplasms and Cancer Survivors, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome: time to complete the recruitment (time frame: Immediately after completion of the intervention (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.