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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer-related Fatigue
• Intervention / Treatment: Diagnostic test: Fatigue Screening and assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Karen Steindorf, Prof. Dr.; Phone Number: +49 6221 42 2351; Email: k.steindorf@dkfz.de
• Study Contact Backup: Name: Patricia Blickle; Phone Number: +49 6221 42 3506; Email: patricia.blickle@dkfz.de

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • German Cancer Research Center
      • Contact: Karen Steindorf, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

cancer patients from any cancer entity at any cancer stage

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Physical activity	assessed by a questionnaire regarding walking, cycling, and exercise behavior	Baseline - 18 months
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
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
Distress	assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress	Baseline - 18 months
Occupational Issues (Past)	Pre-diagnosis working status, 2 items	T4 (18 months)
Occupational Issues (Present)	Current working status, 4 items	T4 (18 months)
EORTC single item	suffering from hot flashes, 4-point Likert scale. A higher value means more suffering.	Baseline - 18 months
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

Collaborators and Investigators

• Sponsor: German Cancer Research Center
• Collaborators: National Center for Tumor Diseases, Heidelberg
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: MERLIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No