Clinical trial NCT05448573: A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening
Official title: Müdigkeit Und Erschöpfung Rechtzeitig Erkennen Und LINdern - a Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer-related Fatigue
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: National Center for Tumor Diseases, Heidelberg
First posted: 2022-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer patients from any cancer entity at any cancer stage

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1st fatigue screening
timeFrame: Baseline - 18 months
measure: 2nd fatigue screening
timeFrame: Baseline - 18 months
measure: 3rd fatigue screening
timeFrame: Baseline - 18 months
measure: Cancer-related fatigue (as reference criterion)
timeFrame: Baseline - 18 months
Secondary outcomes:
measure: Multidimensional fatigue
timeFrame: Baseline - 18 months
measure: Fatigue impact
timeFrame: Baseline - 18 months
measure: Quality of life, function and symptoms
timeFrame: Baseline - 18 months
measure: Depressive symptoms and anxiety
timeFrame: Baseline - 18 months
measure: Physical activity
timeFrame: Baseline - 18 months
measure: Sleep disorders
timeFrame: Baseline - 18 months
measure: Fatigue Coping
timeFrame: 3 months - 18 months
measure: Distress
timeFrame: Baseline - 18 months
measure: Occupational Issues (Past)
timeFrame: T4 (18 months)
measure: Occupational Issues (Present)
timeFrame: T4 (18 months)
measure: EORTC single item
timeFrame: Baseline - 18 months
measure: Social Support
timeFrame: Baseline - 18 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center
state: Baden-Württemberg
Study officials:
affiliation: German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany
name: Karen Steindorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany
name: Martina E. Schmidt, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany
name: Alexander Haussmann, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany
name: Anne Katrin Berger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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