NCT05448573

Brief Summary

MERLIN will include 300 cancer patients at the beginning of their systemic cancer therapy. Patients' fatigue-levels will be surveyed at short time intervals during their cancer therapy and at longer intervals during the subsequent post-treatment phase.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 26, 2025

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

June 13, 2022

Last Update Submit

March 24, 2025

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (4)

  • 1st fatigue screening

    based on the first Cella-criterion, 3 (dichotomous) items

    Baseline - 18 months

  • 2nd fatigue screening

    Visual Analogue Scale (VAS) for Energy, 1 item (Numeric Rating Scale 0-10), higher values meaning higher energy levels.

    Baseline - 18 months

  • 3rd fatigue screening

    short Fatigue impact, 1 item (Numeric Rating Scale 0-10), higher values meaning higher fatigue impact on daily functioning.

    Baseline - 18 months

  • Cancer-related fatigue (as reference criterion)

    based on Cella criteria, 11 (dichotomous) items

    Baseline - 18 months

Secondary Outcomes (12)

  • Multidimensional fatigue

    Baseline - 18 months

  • Fatigue impact

    Baseline - 18 months

  • Quality of life, function and symptoms

    Baseline - 18 months

  • Depressive symptoms and anxiety

    Baseline - 18 months

  • Physical activity

    Baseline - 18 months

  • +7 more secondary outcomes

Interventions

Fatigue Screening and assessmentDIAGNOSTIC_TEST

(Newly) diagnosed cancer-patients from any cancer entity. No intervention.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cancer patients from any cancer entity at any cancer stage

You may qualify if:

  • having received a cancer diagnosis (any entity, any stage)
  • before or within the first month of systemic therapy or radiotherapy against this cancer
  • age ≥ 18 years
  • having the ability to consent to the study

You may not qualify if:

  • previous systemic cancer therapies or radiotherapy within the last 6 months
  • diagnosis of chronic fatigue syndrome / myeloid encephalitis
  • unable to understand the study protocol and complete scheduled assessments during the study period (e.g., for language, cognitive, medical, or organizational reasons)
  • not able to complete the survey online via smartphone, PC, or tablet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

  • Blickle P, Haussmann A, Holzner B, Berger AK, Steindorf K, Schmidt ME. Providing the basis for a patient-centred and effective screening for cancer-related fatigue (MERLIN study): design of a longitudinal observational study. BMJ Open. 2023 Sep 28;13(9):e073802. doi: 10.1136/bmjopen-2023-073802.

    PMID: 37770278DERIVED

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Karen Steindorf, Prof. Dr.

    German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany

    PRINCIPAL INVESTIGATOR

  • Martina E. Schmidt, Dr.

    German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany

    PRINCIPAL INVESTIGATOR

  • Alexander Haussmann, Dr.

    German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany

    PRINCIPAL INVESTIGATOR

  • Anne Katrin Berger, Prof. Dr.

    National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

July 7, 2022

Study Start

October 20, 2022

Primary Completion

August 17, 2024

Study Completion

September 1, 2025

Last Updated

March 26, 2025

Record last verified: 2024-12

Locations

DE(1)