Continuous nursing at home for well-being after stomach cancer surgery
| ISRCTN | ISRCTN50246966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50246966 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | First Hospital of China Medical University |
| Funder | Investigator initiated and funded |
- Submission date
- 31/10/2025
- Registration date
- 25/11/2025
- Last edited
- 05/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Gastric cancer (GC) is the fifth most common malignant tumor in the world in terms of incidence rate and the second most common malignant tumor in terms of mortality. The postoperative condition of patients with GC metastasis is still poor. How to effectively improve the quality of life (QoL) of postoperative patients has gradually become the key target of current treatment. This study aimed to explore the impact of continuous nursing care on the QoL of GC lung metastasis patients, to better implement treatment for GC patients and improve their QoL.
Who can participate?
Patients who have a confirmed diagnosis of stomach cancer that has spread to the lungs.
What does the study involve?
This study will compare two interventions: routine nursing care, which involves regular telephone follow-ups and continuous nursing care, which involves a structured program of telephone follow-ups, scheduled home visits, priority appointments at a specialist clinic, and support through an online health platform.
These measurements will be taken at the time of hospital discharge, and again at 3 months, 6 months, and 1 year after discharge using a questionnaire.
What are the possible benefits and risks of participating?
By enrolling, participants might gain access to a new and potentially better treatment that isn't available to everyone, all while receiving very close medical care from a team of experts. The research team will explain all the known risks, like tiredness or disturbance, in detail.
Where is the study run from?
The First Hospital of China Medical University, Shenyang, China.
When is the study starting and how long is it expected to run for?
June 2022 to October 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Yueyang Jiang, yueyang_jiang@hotmail.com
Contact information
Public, Scientific, Principal investigator
No. 155 Nanjing North Street
Heping District
Shenyang
110001
China
| Phone | +86 (0)18640553991 |
|---|---|
| Yueyang_jiang@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of continuous nursing care on postoperative quality of life in patients with gastric cancer lung metastasis |
| Study objectives | This study aimed to explore the impact of continuous nursing care on the quality of life (QoL) of gastric cancer (GC) lung metastasis patients, to better implement treatment for GC patients and improve their QoL. |
| Ethics approval(s) |
Approved 17/07/2025, Ethics Committee of the First Hospital of China Medical University (No. 155 Nanjing North Street, Heping District, Shenyang City, 110001, China; -; ethics@cmu1h.com), ref: 101022119 |
| Health condition(s) or problem(s) studied | Gastric cancer |
| Intervention | This was a 1-year follow-up study where 102 patients with GC lung metastasis in the First Hospital of China Medical University were randomized to routine telephone follow-ups (Control) or a comprehensive continuous nursing program involving phone calls, home visits, clinic services, and online support (Observation).The anxiety, depression and QoL scores of patients: physical function, role function, emotional function, cognitive function, and social function, were observed at the time of discharge, 3 months, 6 months and 1 year after discharge. Control Group Protocol: the patents received regular telephone follow-ups conducted by a nurse specialist, which included: medication guidance, dietary counseling and mental health monitoring. All follow-up records were documented in a discharge follow-up logbook. The randomization process was designed to ensure robustness and minimize bias, beginning with a computer-generated random number sequence created by an independent statistician uninvolved in patient care. Assignment occurred only after patients had provided informed consent and their eligibility was definitively confirmed. To enforce allocation concealment, sequentially numbered, opaque, sealed envelopes were used, and a research nurse opened each envelope solely after a participant’s baseline assessment was complete, thereby ensuring the enrolling team remained blinded to the upcoming group assignment throughout implementation. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The following primary outcome measures were assessed at discharge, 3 and 6 months, and 1 year after discharge: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 102 |
| Key inclusion criteria | 1. Pathologically confirmed diagnosis of gastric cancer with lung metastasis 2. Possessing self-awareness and ability to cooperate in answering questions 3. Patients who showed clinical improvement after surgical treatment |
| Key exclusion criteria | 1. Comorbidities with other severe systemic diseases 2. Patients with cognitive dysfunction 3. Patients unwilling to cooperate with home visits 4. Other reasons preventing participation |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Heping District
Shenyang
110001
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Mrs Yueyang Jiang (Yueyang_jiang@hotmail.com) |
Editorial Notes
04/11/2025: Study's existence confirmed by The First Hospital of China Medical University, China.
