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Cancer-related FatigueMERLINNCT05448573

A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening

An observational study of Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cancer-related Fatigue
What is being tested?
Fatigue Screening and assessment
How many people
300 participants
Where
1 siteGermany
Study dates
20 Oct 2022to Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: cancer patients from any cancer entity at any cancer stage

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • German Cancer Research Center

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: Müdigkeit Und Erschöpfung Rechtzeitig Erkennen Und LINdern - a Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening

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.

Read the detailed description

MERLIN aims to answer the question, how a fatigue screening tool should be designed for use in clinical practice to reliably and efficiently detect fatigue in cancer patients.

Patients will be surveyed at short time intervals during their cancer therapy (every 1-2 weeks) and at longer intervals during the subsequent post-treatment phase (every 4-6 weeks).

In addition, important psychological factors, which may exacerbate fatigue or contribute to its maintenance will be assessed at baseline, after 3, 6, 12 and 18 months (e.g. depressive symptoms, anxiety, sleep disturbances, coping). These data will be collected by online questionnaires.

Additional data, e.g. medical history, cancer characteristics and treatment as well as concomitant medication and complementary therapies will be extracted from the clinical documentation systems.

In total, the study will provide important information for the establishment of a patient-oriented fatigue screening. Thus, MERLIN will contribute to the early detection and alleviation of this frequent and distressing side effect of cancer treatment.

Being tested
Fatigue Screening and assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fatigue Screening and assessmentDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1st fatigue screening

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

    Measured: Baseline - 18 months

  2. 2nd fatigue screening

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

    Measured: Baseline - 18 months

  3. 3rd fatigue screening

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

    Measured: Baseline - 18 months

  4. Cancer-related fatigue (as reference criterion)

    based on Cella criteria, 11 (dichotomous) items

    Measured: Baseline - 18 months

Secondary outcomes (12)

  1. Multidimensional fatigue

    EORTC QLQ - FA12 (physical, emotional, and cognitive dimension). The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much) with higher scores meaning a higher level of fatigue.

    Measured: Baseline - 18 months

  2. Fatigue impact

    Brief Fatigue Inventory (BFI). The BFI consists of an 11-point numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine) with higher scores signifying higher intensity and impairment

    Measured: Baseline - 18 months

  3. Quality of life, function and symptoms

    assessed by the EORTC QLQ-C30. The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). A higher score corresponds to a higher level of symptoms/problems

    Measured: Baseline - 18 months

  4. Depressive symptoms and anxiety

    assessed by the Patient Health Questionnaire (PHQ-4), 4 items. The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score is calculated, with higher scores meaning a higher level of depressive symptoms and anxiety

    Measured: Baseline - 18 months

  5. Physical activity

    assessed by a questionnaire regarding walking, cycling, and exercise behavior

    Measured: Baseline - 18 months

  6. Sleep disorders

    assessed by the PSQI (Pittsburgh Sleep Quality Index).The PSQI consists of open and closed questions regarding characteristics of sleep and sleep quality. Some items are rated on a 4-point likert scale with higher scores meaning more sleep problems.

    Measured: Baseline - 18 months

  7. Fatigue Coping

    assessed by an adapted Brief COPE questionnaire. The questionnaire consists of 14 items and the items are rated on a 4-point Likert scale with higher scores meaning higher use of the coping strategy described

    Measured: 3 months - 18 months

  8. Distress

    assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress

    Measured: Baseline - 18 months

  9. Occupational Issues (Past)

    Pre-diagnosis working status, 2 items

    Measured: T4 (18 months)

  10. Occupational Issues (Present)

    Current working status, 4 items

    Measured: T4 (18 months)

  11. EORTC single item

    suffering from hot flashes, 4-point Likert scale. A higher value means more suffering.

    Measured: Baseline - 18 months

  12. Social Support

    assessed by the Illness-specific Social Support Scale (ISSS, German Version) among cancer patients. The 8 items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Sum scores for the items 1,3,6 and 8 (positive support) as well as for the items 2,4,5 and 7 (detrimental interaction) are calculated with higher scores meaning higher levels of positive support and detrimental interaction respectively.

    Measured: Baseline - 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start20 Oct 2022
  3. Primary completion17 Aug 2024
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448573
Sponsor's protocol ID
MERLIN
Acronym
MERLIN
Status last verified
Dec 2024
First submitted
13 Jun 2022
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37770278

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1st fatigue screening (time frame: Baseline - 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448573, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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