- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07656324
Epidemiology and Prognostic Analysis of Chinese Cancer Patients With Cancer-related Fatigue
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Hongxia Wang, PhD
- Telefonnummer: 021-33988888
- E-post: whx365@126.com
Studer Kontakt Backup
- Navn: Juan Jin, PhD
- Telefonnummer: 021-33988888
- E-post: medjinjuan@126.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Patients with malignant tumors
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Ingen inngrep
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The incidence of cancer-related fatigue (CRF) in tumor patients.
Tidsramme: Baseline
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The incidence of cancer-related fatigue (CRF) in tumor patients.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The severity grading of cancer-related fatigue (CRF) in tumor patients across different tumor types and multiple treatment settings.
Tidsramme: Baseline
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The severity grading of cancer-related fatigue (CRF) in tumor patients across different tumor types and multiple treatment settings.
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Baseline
|
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The correlation between treatment regimen and the incidence of cancer-related fatigue (CRF).
Tidsramme: Baseline
|
Baseline
|
|
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The incidence of anti-tumor treatment delays, dose reductions, or regimen modifications due to cancer-related fatigue (CRF).
Tidsramme: Baseline
|
Baseline
|
|
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Progression-free survival (PFS) and overall survival (OS) in patients with different grades of cancer-related fatigue (CRF) undergoing anti-tumor therapy.
Tidsramme: Baseline
|
Baseline
|
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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).
Tidsramme: Baseline
|
Baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRF-01 (Annen identifikator: Fudan University Shanghai Cancer Center)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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