NCT07307404

Brief Summary

It is crucial to promptly identify nutritional issues in these patients within the community and provide them with dietary guidance, nutritional counseling, and support. This study will be conducted in communities in Chengdu, Sichuan. Community management teams will register oncology patients, collecting information such as demographic data, tumor type, stage, specific treatment plan, treatment hospital, regularity of hospital admissions, and frequency of independent smartphone use. Registered patients will be screened based on inclusion and exclusion criteria. For those who meet the criteria, the community management team will contact them and recommend the use of a dedicated app developed by the research team. An initial nutritional assessment will also be conducted. Patients identified with nutritional risks will be directly referred to the research team's clinical nutritionists for face-to-face consultations. After additional tests, such as body composition analysis, necessary nutritional education and stepwise nutritional interventions will be provided. These patients will also use the app for dietary monitoring and nutritional guidance. For patients without nutritional risks, the app will be recommended for daily questionnaire completion and activity tracking.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Apr 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 17, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

cancer

Outcome Measures

Primary Outcomes (1)

  • body weight change

    change of body weight during the trail

    baseline, pre-intervention;every 2 weeks after randomization until 6 moths.

Secondary Outcomes (2)

  • PG-SGA

    baseline, pre-intervention;every 2 weeks after randomization until 6 moths.

  • NRS2002

    baseline, pre-intervention;every 2 weeks after randomization until 6 moths.

Other Outcomes (3)

  • EORTC QLQ C30

    baseline, pre-intervention;every 4 weeks after randomization until 6 moths.

  • caregiver burden

    baseline, pre-intervention;every 4 weeks after randomization until 6 moths.

  • psychology characteristics

    baseline, pre-intervention;every 4 weeks after randomization until 6 moths.

Study Arms (2)

intervention group

EXPERIMENTAL

Self-Intervention: During the period of staying at home, patients use the app developed by the team for self-intervention, including dietary monitoring and check-ins, nutritional risk assessment, learning of educational knowledge, and online expert consultations. Community Intervention: When nutritional risks are detected, pop-up alerts will notify patients to communicate with the community management team. Patients can seek basic nutritional consultations and receive advice from the community management team. If necessary, the management team will refer patients to relevant higher-level hospital outpatient clinics for further care. If patients experience other issues related to their primary condition, the community management team will refer them to community healthcare providers for consultation and treatment. The community will also organize thematic lectures on nutritional management for cancer patients, with oncologists and nutritionists providing regular voluntary consultatio

Other: nutrtion care based on app

standard care

NO INTERVENTION

standard nutrtion care

Interventions

Self-Intervention: During the period of staying at home, patients use the app developed by the team for self-intervention, including dietary monitoring and check-ins, nutritional risk assessment, learning of educational knowledge, and online expert consultations. Community Intervention: When nutritional risks are detected, pop-up alerts will notify patients to communicate with the community management team. Patients can seek basic nutritional consultations and receive advice from the community management team. If necessary, the management team will refer patients to relevant higher-level hospital outpatient clinics for further care. If patients experience other issues related to their primary condition, the community management team will refer them to community healthcare providers for consultation and treatment. The community will also organize thematic lectures on nutritional management for cancer patients, with oncologists and nutritionists providing regular voluntary consultation

intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed malignant tumor;
  • PG-SGA score of 4-9 points;
  • Age: ≥18 years, with an expected survival time of more than 1 year;
  • Possesses adequate cognitive and reading abilities to complete questionnaires and use the APP.

You may not qualify if:

  • Presence of neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis of tumors;
  • Suffering from conditions severely impacting digestion, metabolism, or food intake;
  • Patients in the cachexia stage or refractory cachexia phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xingchen Peng

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 29, 2025

Study Start

December 30, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations