Health TrialsbyHealthPanel

Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy

ConditionGastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Friendship Hospital

About this trial

The goal of this clinical trial is to investigate the effects of a perioperative multimodal rehabilitation program on the incidence of postoperative complications and perioperative clinical indexes including functional capacity, nutritional and psychological status in patients with gastric cancer undergoing neoadjuvant therapy. Besides the investigators also develop a smart phone based digital platform aiming to evaluate its effectiveness in improving patient adherence, compared with the conventional telephone supervision approach. The main questions it aims to answer are:

* Can the perioperative multimodal rehabilitation program reduce postoperative complications in patients with gastric cancer undergoing neoadjuvant therapy? * Can the smart phone based digital platform improve patients' adherence compared to traditional telephone supervision? * Can the perioperative multimodal rehabilitation program improve the perioperative clinical indicators of patients with gastric cancer undergoing neoadjuvant therapy, including functional capacity, nutritional status and psychological condition? The investigators will compare the perioperative multimodal rehabilitation program with the standard treatment alone to determine whether this program has the effects mentioned above.

Participants will follow the perioperative multimodal rehabilitation program from neoadjuvant therapy through to four weeks after discharge.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients aged between 18 and 70 years;

patients with histologically confirmed resectable adenocarcinoma of the oesophago gastric junction or stomach;

patients referred by a multidisciplinary team (MDT) for neoadjuvant therapy;

patients able to use a smartphone and the digital follow up platform, and willing to comply with regular follow up assessments;

Disqualifiers

presence of distant metastasis;

severe cardiopulmonary disease or other contraindications precluding completion of the 6MWT or participation in exercise training;

concurrent other malignant tumours;

suspected recurrent gastric cancer;

Trial design

Design model

Parallel

Treatments tested in this trial

  • perioperative multimodal rehabilitation program with telephone supervision

    Behavioral

    The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by standardized meal plans and nutritional reference materials. The psychological intervention includes weekly motivational videos and psychoeducational content, supplemented by regular assessment of emotional and cognitive status using validated scales. Patients independently follow the program, and record all activities in a rehabilitation diary, which will be returned post-trial.Additionally, patients will receive a weekly telephone call, to assess adherence to the program.

  • Usual Care

    Procedure/Surgery

    Patients receive usual care throughout their cancer pathway. Besides, we will provide verbal exercise, dietary, and psychological advice to patients but did not provide written advice and supervision.

  • perioperative multimodal rehabilitation program with digital supervision

    Behavioral

    The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by standardized meal plans and nutritional reference materials. The psychological intervention includes weekly motivational videos and psychoeducational content, supplemented by regular assessment of emotional and cognitive status using validated scales. The digital platform provides personalized exercise videos, nutritional logging tools, and psychological modules. Researchers monitor engagement metrics weekly to guide adjustments.

Treatment groups

186 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Telephone therapeutic groupExperimental treatment 1 intervention
Group C: Digital therapeutic groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complications at 90 days after surgery

The primary outcome of the study is the postoperative morbidity rate by the Clavien-Dindo classification at 90 days postoperatively. All postoperative complications will be documented at discharge and the surgeon will record any events after discharge at the outpatient appointment 90 days postoperatively. All complications will be classified by the Clavien-Dindo classification.

Time frame
From the time of the surgery to 90 days postoperatively

Secondary outcomes

1

Adherence--(1)Assessment completion rate

In the telephone therapeutic group , patients use a rehabilitation diary to report their progress throughout the perioperative multimodal rehabilitation program. Besides, adherence is additionally assessed by researchers through a structured adherence assessment form during the scheduled weekly calls. In the digital therapeutic group, all completion data are recorded directly by the digital platform. It is measured by the completion status of the adherence assessment form or the completion data recorded by the digital platform.

Time frame
From enrollment to 4 weeks after discharge
2

Adherence--(2)The mean number of training sessions attended

Time frame
From enrollment to 4 weeks after discharge
3

Adherence--(3)The number of patients requiring exercise intensity adjustment

Time frame
From enrollment to 4 weeks after discharge
4

Adherence--(4)The number of patients requiring early termination of the intervention

Time frame
From enrollment to 4 weeks after discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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