Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy

Sponsor
Beijing Friendship Hospital
Study ID
NCT07441850
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Mar 1, 2026
Status verified
Jul 2026
Primary completion
Mar 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    Patients in control group 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
  • Experimental: Telephone therapeutic group
    Patients in telephone therapeutic group receive the perioperative multimodal rehabilitation programme, with supervision delivered via conventional telephone calls.
  • Experimental: Digital therapeutic group
    Patients in digital therapeutic group receive the same perioperative multimodal rehabilitation programme but with all supervision conducted through a smart phone based digital platform. The mode of supervision is thus the key variable that distinguishes the telephone therapeutic group.

Primary Outcome Measure

Complications at 90 days after surgery [ Time Frame: From the time of the surgery to 90 days postoperatively ]

Central Contacts

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