Epidemiology and Prognostic Analysis of Chinese Cancer Patients With Cancer-related Fatigue

June 15, 2026 updated by: Hongxia Wang, Fudan University
This investigator-initiated study aims to evaluate the incidence and severity of cancer-related fatigue (CRF) in patients with malignant tumors, to analyze the influencing factors of CRF, and to explore its impact on anti-tumor treatment and prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This investigator-initiated study aims to evaluate the incidence and severity of cancer-related fatigue (CRF) in patients with malignant tumors, to analyze the influencing factors of CRF, and to explore its impact on anti-tumor treatment and prognosis. Using patient-completed questionnaires, combined with outpatient visit records and telephone follow-up, this study will explore the following aspects:

Assess the incidence and severity of cancer-related fatigue in patients with malignant tumors.

Analyze the influencing factors of cancer-related fatigue, including tumor type, treatment regimen, disease stage, efficacy of anti-tumor therapy, adverse events associated with anti-tumor therapy, and concomitant medications.

Evaluate the impact of cancer-related fatigue on anti-tumor treatment and prognosis.

Assess the multidimensional state and severity of cancer-related fatigue in patients with malignant tumors using the Brief Fatigue Inventory - Cancer (BFI-C) and the Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF).

By collecting patients' medical information, including imaging and laboratory results, as well as outpatient and telephone follow-up records, this study will explore the following aspects:

Evaluate the impact of different degrees of cancer-related fatigue on the prognosis of patients with malignant tumors.

Explore the impact of the efficacy of anti-tumor therapy on the multidimensional state and severity of cancer-related fatigue in patients.

Study Type

Observational

Enrollment (Estimated)

1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongxia Wang, PhD
  • Phone Number: 021-33988888
  • Email: whx365@126.com

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with malignant tumors in various tumor types and multiple treatment scenarios.

Description

Inclusion Criteria:

  1. Male or female, aged 18 years or older.
  2. Able to understand the purpose of this survey study, willing to participate, and able to sign an informed consent form.
  3. Malignant tumor confirmed histologically or cytologically.

Exclusion Criteria:

  1. Pregnant or breastfeeding women.
  2. Patients with acute or chronic infections, or those with other serious medical conditions that, in the investigator's judgment, make them unsuitable for this study.
  3. Patients with two or more concurrent malignant tumors (excluding the following: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma).
  4. Patients with psychiatric illness or mental disorders, poor compliance, or who are unable to cooperate and report treatment responses.
  5. Patients with severe organic disease or major organ failure, such as decompensated heart, lung, liver, or kidney failure.
  6. Patients with other conditions that, in the investigator's opinion, make them unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with malignant tumors
  1. Male or female, aged 18 years or older.
  2. Able to understand the purpose of this survey study, willing to participate, and able to sign an informed consent form.
  3. Malignant tumor confirmed histologically or cytologically.
Other: No Interventions
No Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of cancer-related fatigue (CRF) in tumor patients.
Time Frame: Baseline
The incidence of cancer-related fatigue (CRF) in tumor patients.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity grading of cancer-related fatigue (CRF) in tumor patients across different tumor types and multiple treatment settings.
Time Frame: Baseline
The severity grading of cancer-related fatigue (CRF) in tumor patients across different tumor types and multiple treatment settings.
Baseline
The correlation between treatment regimen and the incidence of cancer-related fatigue (CRF).
Time Frame: Baseline
Baseline
The incidence of anti-tumor treatment delays, dose reductions, or regimen modifications due to cancer-related fatigue (CRF).
Time Frame: Baseline
Baseline
Progression-free survival (PFS) and overall survival (OS) in patients with different grades of cancer-related fatigue (CRF) undergoing anti-tumor therapy.
Time Frame: Baseline
Baseline
To assess the state and severity of cancer-related fatigue (CRF) in patients with malignant tumors using the Brief Fatigue Inventory - Cancer (BFI-C) and the Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF).
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Estimated)

January 17, 2027

Study Completion (Estimated)

January 17, 2027

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRF-01 (Other Identifier: Fudan University Shanghai Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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