The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor,

Completed

• Conditions: Fatigue Syndrome, Chronic; Quality of Life; Bone Tumor

• Registration Number: NCT04104750
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Study Timeline

• Study Start: 2019-07-26
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Primary Completion: 2022-08-20
• Study Completion: 2024-03-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• patients diagnosed with bone tumors who start a new chemotherapy treatment protocol

Exclusion Criteria

• patients with little knowledge of the Italian language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the patient's Fatigue	through study completion, an average of 5years	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 Outcome Measures

Name	Time	Method
the quality of life of patients	through study completion, an average of 5years	Quality of life of patients measured by the European Organisation for Research and Treatment of Cancer quality of life scale

Trial Locations

Locations (1)

Paola Coluccino; 🇮🇹 Bologna, BO, Italy