NCT07656324

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 17, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 18, 2025

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2027

Last Updated

June 18, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 18, 2025

Last Update Submit

June 15, 2026

Conditions

Cancer

Keywords

FatigueCancer

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline

Secondary Outcomes (5)

  • 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).

    Baseline

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

    Baseline

  • Progression-free survival (PFS) and overall survival (OS) in patients with different grades of cancer-related fatigue (CRF) undergoing anti-tumor therapy.

    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).

    Baseline

Study Arms (1)

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

Interventions

No InterventionsOTHER

No Interventions

Patients with malignant tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hongxia Wang, PhD

CONTACT

021-33988888whx365@126.com

Juan Jin, PhD

CONTACT

021-33988888medjinjuan@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pro

Study Record Dates

First Submitted

January 18, 2025

First Posted

June 18, 2026

Study Start

January 17, 2025

Primary Completion (Estimated)

January 17, 2027

Study Completion (Estimated)

January 17, 2027

Last Updated

June 18, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)