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

German Cancer Research Center

Status: Active, not recruiting

Conditions: Cancer-related Fatigue

Treatments: Diagnostic Test: Fatigue Screening and assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05448573

MERLIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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