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Active, Not Recruiting

NCT Number: NCT05448573

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer-related Fatigue

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

German Cancer Research Center

Heidelberg, Baden-Wurttemberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fatigue Screening and assessment

Diagnostic Test

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

Primary outcomes

  1. 1st fatigue screening

    Time frame: Baseline - 18 months

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

  2. 2nd fatigue screening

    Time frame: Baseline - 18 months

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

  3. 3rd fatigue screening

    Time frame: Baseline - 18 months

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

  4. Cancer-related fatigue (as reference criterion)

    Time frame: Baseline - 18 months

    based on Cella criteria, 11 (dichotomous) items

Secondary outcomes

  1. Multidimensional fatigue

    Time frame: Baseline - 18 months

    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.

  2. Fatigue impact

    Time frame: Baseline - 18 months

    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

  3. Quality of life, function and symptoms

    Time frame: Baseline - 18 months

    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

  4. Depressive symptoms and anxiety

    Time frame: Baseline - 18 months

    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

  5. Physical activity

    Time frame: Baseline - 18 months

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

  6. Sleep disorders

    Time frame: Baseline - 18 months

    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.

  7. Fatigue Coping

    Time frame: 3 months - 18 months

    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

  8. Distress

    Time frame: Baseline - 18 months

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

  9. Occupational Issues (Past)

    Time frame: T4 (18 months)

    Pre-diagnosis working status, 2 items

  10. Occupational Issues (Present)

    Time frame: T4 (18 months)

    Current working status, 4 items

  11. EORTC single item

    Time frame: Baseline - 18 months

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

  12. Social Support

    Time frame: Baseline - 18 months

    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.

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • National Center for Tumor Diseases, Heidelberg

Registry information

Official study title

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

Acronym: MERLIN

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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