A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening
- Conditions
- Cancer-related Fatigue
- Registration Number
- NCT05448573
- Lead Sponsor
- German Cancer Research Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1st fatigue screening Baseline - 18 months based on the first Cella-criterion, 3 (dichotomous) items
2nd fatigue screening Baseline - 18 months Visual Analogue Scale (VAS) for Energy, 1 item (Numeric Rating Scale 0-10), higher values meaning higher energy levels.
3rd fatigue screening Baseline - 18 months short Fatigue impact, 1 item (Numeric Rating Scale 0-10), higher values meaning higher fatigue impact on daily functioning.
Cancer-related fatigue (as reference criterion) Baseline - 18 months based on Cella criteria, 11 (dichotomous) items
- Secondary Outcome Measures
Name Time Method Distress Baseline - 18 months assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress
Quality of life, function and symptoms 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
Fatigue impact 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
Depressive symptoms and anxiety 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
Physical activity Baseline - 18 months assessed by a questionnaire regarding walking, cycling, and exercise behavior
Fatigue Coping 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
Social Support 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.
Multidimensional fatigue 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.
Occupational Issues (Past) T4 (18 months) Pre-diagnosis working status, 2 items
Sleep disorders 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.
EORTC single item Baseline - 18 months suffering from hot flashes, 4-point Likert scale. A higher value means more suffering.
Occupational Issues (Present) T4 (18 months) Current working status, 4 items
Trial Locations
- Locations (1)
German Cancer Research Center
🇩🇪Heidelberg, Baden-Württemberg, Germany