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Prospective randomized controlled study on the impact of patient-reported outcomes on the quality of life of patients with gastrointestinal tumors undergoing chemotherapy in pastoral and agricultural areas

Prospective randomized controlled study on the impact of patient-reported outcomes on the quality of life of patients with gastrointestinal tumors undergoing chemotherapy in pastoral and agricultural areas

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104939
Enrollment
Unknown
Registered
2025-06-25
Start date
2025-04-22
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

The group of patient-reported outcomes (PRO group):Patient-reported outcomes (PRO), and relevant symptomatic interventions were carried out based on the early warning values of the questionnaire

Sponsors

Ordos Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years old, who have been pathologically diagnosed with gastrointestinal malignant tumors, have household registration in pastoral and agricultural areas (rural areas at the county level and below, pastoral areas), and currently live in pastoral and agricultural areas for a long time; 2. Patients who are planned to receive chemotherapy regimens based on oxaliplatin, irinotecan or fluorouracil, including SOX, XELOX, FOLFOX, FOLFIRI, XELRI regimens. Combination of the above regimens with PD-1, bevacizumab or cetuximab is allowed; 3. Karnofsky Performance Status (KPS) score >= 70 points; 4. No obvious abnormalities in liver and kidney functions, routine blood tests, and electrocardiogram before chemotherapy. Blood tests must meet the following criteria: platelet count > 85×10?/L, white blood cell count > 3.5×10?/L, neutrophil count > 1.5×10?/L, serum alanine aminotransferase and aspartate aminotransferase = 12 months and plan to receive >= 4 cycles of chemotherapy; 6. Provide informed consent and be able to complete WeChat follow-up; 7. The patient himself/herself or a direct relative has a mobile phone device that can answer calls or receive text messages, and is able to complete filling out the EORTC QLQ-C30 quality of life scale independently or with the assistance of a family member.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot understand the research content. 2. Tumor patients who change the treatment method or chemotherapy regimen. 3. Patients with severe mental illness or cognitive impairment who cannot cooperate with the research. 4. Patients who voluntarily terminate anti-tumor chemotherapy or interrupt chemotherapy due to other serious diseases during chemotherapy. 5. Patients with low participation and cooperation who cannot complete regular follow-up. 6. Patients who participate in other interventional clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
Health-related quality of life (HRQOL);

Secondary

MeasureTime frame
The duration of adverse reactions after chemotherapy.;

Countries

China

Contacts

Public ContactLi Quanfu

Ordos Central Hospital

1729259137@qq.com+86 477 836 3279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026