Recruiting NCT07656324

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

— Observational Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: No Interventions.
Who it may be relevant to: Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

Other No Interventions
No Interventions

Primary outcome measures

The incidence of cancer-related fatigue (CRF) in tumor patients. [Time frame: Baseline]

Secondary outcome measures (5)

The severity grading of cancer-related fatigue (CRF) in tumor patients across different tumor types and multiple treatment settings. [Time frame: Baseline]
The correlation between treatment regimen and the incidence of cancer-related fatigue (CRF). [Time frame: Baseline]
The incidence of anti-tumor treatment delays, dose reductions, or regimen modifications due to cancer-related fatigue (CRF). [Time frame: 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]
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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

China · 1 center

Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07656324 · CRF-01 · CRF-01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗