NCT04104750

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Fatigue syndrome It is a clinical condition, linked to the oncological pathology, extremely widespread and in patients undergoing chemotherapy and / or radiotherapy it is common in 80% of patients. Literature stress the need for systematic studies in cancer populations with different types of cancer and at different stages of the disease using patient-oriented fatigue assessment tools. The Brief Fatigue Inventory (BFI) is one of the scales used precisely in the evaluation of this syndrome and has proved to be a reliable and easy to use tool, also validated in Italian. Several authors have also shown that reduced physical activity and a worse quality of life are associated with fatigue, particularly in young patients.Several authors describe the experience of 11 new sarcoma patients undergoing chemotherapy treatment. Fatigue had been described as the prevalent symptom and was related to a worse quality of life.

Conditions

• Fatigue Syndrome, Chronic
• Bone Tumor
• Quality of Life

Interventions

Type	Name	Description
OTHER	assessment scales (BFI, QLQ, TESS)	the patient's Fatigue will be measured during the treatment period with antiblastic drugs and part of the followup period. To this end the BFI scale validated in Italian will be used (Mendoza et al 1999; Catania et al, 2013) which includes 9 items with a score for each of 0 to 10 and a consequent total score from 0 to 90. The measurement will take place in 4 times: the day of enrollment, 6 months, 12 months and 24 months after enrollment.the quality of life of patients measured by the EORTC QLQ C-30 scale (Aaronson et al, 1993) and the level of autonomy measured by the TESS scale (Davis et al, 1996) in 4 steps: the enrollment day , at 6 months, at 12 months and at 24 months from enrollment.

Timeline

• Start date: 2019-07-26
• Primary completion: 2022-08-20
• Completion: 2024-03-20
• First posted: 2019-09-26
• Last updated: 2024-07-18

Locations

1 site across 1 country: Italy