Epidemiology and Prognostic Analysis of Chinese Cancer Pa... | NCT07656324

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

NCT07656324

Sponsor

Fudan University

Status

Recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

1,000,000Estimated

Phase

Not provided

Conditions

Cancer

Interventions

No Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CRF-01	Other Identifier	Fudan University Shanghai Cancer Center

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2025Actual

Primary Completion Date

Jan 17, 2027Estimated

Completion Date

Jan 17, 2027Estimated

First Submitted Date

Jan 18, 2025

First Submission Date that Met QC Criteria

Jun 15, 2026

First Posted Date

Jun 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with malignant tumors		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.	Other: No Interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Interventions	Other	No Interventions	Patients with malignant tumors

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
The severity grading of cancer-related fatigue (CRF) in tumor patients across different tumor types and multiple treatment settings.	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).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongxia Wang, PhD	Contact	021-33988888		whx365@126.com
Juan Jin, PhD	Contact	021-33988888		medjinjuan@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009369	Neoplasms
D005221	Fatigue

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms