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

Cancer-related Fatigue Clinical Trial

— MERLIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448573
• Other study ID #: MERLIN
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: German Cancer Research Center
• Contact: Patricia Blickle
• Phone: +49 6221 42 3506
• Email: patricia.blickle[@]dkfz.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

Diagnostic Test:
• Fatigue Screening and assessment
(Newly) diagnosed cancer-patients from any cancer entity. No intervention.

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
German Cancer Research Center	National Center for Tumor Diseases, Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st fatigue screening	based on the first Cella-criterion, 3 (dichotomous) items	Baseline - 18 months
Primary	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
Primary	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
Primary	Cancer-related fatigue (as reference criterion)	based on Cella criteria, 11 (dichotomous) items	Baseline - 18 months
Secondary	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.	Baseline - 18 months
Secondary	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	Baseline - 18 months
Secondary	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	Baseline - 18 months
Secondary	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	Baseline - 18 months
Secondary	Physical activity	assessed by a questionnaire regarding walking, cycling, and exercise behavior	Baseline - 18 months
Secondary	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.	Baseline - 18 months
Secondary	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	3 months - 18 months
Secondary	Distress	assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress	Baseline - 18 months
Secondary	Occupational Issues (Past)	Pre-diagnosis working status, 2 items	T4 (18 months)
Secondary	Occupational Issues (Present)	Current working status, 4 items	T4 (18 months)
Secondary	EORTC single item	suffering from hot flashes, 4-point Likert scale. A higher value means more suffering.	Baseline - 18 months
Secondary	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.	Baseline - 18 months