- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307404
Web-based Platform for Nutrition Management in Patients With Cancer
Web-based Platform for Nutrition Management in Patients With Cancer: A Randomized Clinical Trial
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xingchen Peng
- Phone Number: 18980606753
- Email: pxx2014@163.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital
-
Contact:
- Xingchen Peng
- Phone Number: 18980606753
- Email: pxx2014@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
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 |
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 |
|
No Intervention: standard care
standard nutrtion care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body weight change
Time Frame: baseline, pre-intervention;every 2 weeks after randomization until 6 moths.
|
change of body weight during the trail
|
baseline, pre-intervention;every 2 weeks after randomization until 6 moths.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PG-SGA
Time Frame: baseline, pre-intervention;every 2 weeks after randomization until 6 moths.
|
assessed using the PG-SGA score
|
baseline, pre-intervention;every 2 weeks after randomization until 6 moths.
|
|
NRS2002
Time Frame: baseline, pre-intervention;every 2 weeks after randomization until 6 moths.
|
using nutrition risk screening [NRS 2002]
|
baseline, pre-intervention;every 2 weeks after randomization until 6 moths.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EORTC QLQ C30
Time Frame: baseline, pre-intervention;every 4 weeks after randomization until 6 moths.
|
using Quality-of-Life Questionnaire Core 30
|
baseline, pre-intervention;every 4 weeks after randomization until 6 moths.
|
|
caregiver burden
Time Frame: baseline, pre-intervention;every 4 weeks after randomization until 6 moths.
|
using the 12-Item Zarit Burden Interview [ZBI]
|
baseline, pre-intervention;every 4 weeks after randomization until 6 moths.
|
|
psychology characteristics
Time Frame: baseline, pre-intervention;every 4 weeks after randomization until 6 moths.
|
Hospital Anxiety and Depression Scale [HADS]
|
baseline, pre-intervention;every 4 weeks after randomization until 6 moths.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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