Clinical trial · Observational
The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor,
The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor, Undergoing Chemotherapy Treatment and Possible Predictive Factors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present observational study is to evaluate and describe the evolution over time of the fatigue and the quality of life of patients with bone tumor, in Rizzoli Orthopedic Institute, Chemotherapy ward, during the chemotherapy treatment and in the first phase of follow-up and to identify possible prognostic factors. Such knowledge is a necessary precondition for identifying patients and the periods most at risk due to the onset of fatigue, so as to be able to hypothesize adequate containment strategies.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Tumor | Bone Neoplasm | ALIAS | 0.90 |
| Fatigue Syndrome, Chronic | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment scales (BFI, QLQ, TESS) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the patient's Fatigue
- timeFrame
- through study completion, an average of 5years
- description
- will be measured during the treatment period with antiblastic drugs and part of the followup period. To this end the Brief Fatigue Inventory scale validated in Italian will be used which includes 9 items with a score for each of 0 to 10 and a consequent total score from 0 to 90.
Secondary outcomes (1)
- measure
- the quality of life of patients
- timeFrame
- through study completion, an average of 5years
- description
- Quality of life of patients measured by the European Organisation for Research and Treatment of Cancer quality of life scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * patients diagnosed with bone tumors who start a new chemotherapy treatment protocol Exclusion Criteria: * patients with little knowledge of the Italian language
References
Publications (3)
- RESULTAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- RESULTCatania G, Bell C, Ottonelli S, Marchetti M, Bryce J, Grossi A, Costantini M. Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI). Support Care Cancer. 2013 Feb;21(2):413-9. doi: 10.1007/s00520-012-1539-z. Epub 2012 Jul 13. PMID 22790224
- DERIVEDMorri M, Boccomino R, Brruku E, Romagnoli E, Boschi R, Raucci G, Bellina Terra A, Coluccino P. Fatigue, functional ability and quality of life in patients with bone and soft tissue sarcomas undergoing chemotherapy treatment: An observational study. Eur J Oncol Nurs. 2025 Feb;74:102736. doi: 10.1016/j.ejon.2024.102736. Epub 2024 Nov 16. PMID 39577033