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NCT Number: NCT07656324

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant or breastfeeding women.
  • 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.
  • 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).
  • Patients with psychiatric illness or mental disorders, poor compliance, or who are unable to cooperate and report treatment responses.
  • Patients with severe organic disease or major organ failure, such as decompensated heart, lung, liver, or kidney failure.
  • Patients with other conditions that, in the investigator's opinion, make them unsuitable for participation in this study.

Treatment and study plan

No interventions

Other

No Interventions

Primary outcomes

  1. The incidence of cancer-related fatigue (CRF) in tumor patients.

    Time frame: Baseline

    The incidence of cancer-related fatigue (CRF) in tumor patients.

Secondary outcomes

  1. 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.

  2. The correlation between treatment regimen and the incidence of cancer-related fatigue (CRF).

    Time frame: Baseline

  3. The incidence of anti-tumor treatment delays, dose reductions, or regimen modifications due to cancer-related fatigue (CRF).

    Time frame: Baseline

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxia Wang, PhD

CONTACT

[email protected]

021-33988888

Juan Jin, PhD

CONTACT

[email protected]

021-33988888

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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