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

Quality of Life Clinical Trial

— Fatigue-ONCO  

Official title:

The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor, Undergoing Chemotherapy Treatment and Possible Predictive Factors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04104750
• Other study ID #: Fatigue-ONCO
• Status: Active, not recruiting
• Start date: July 26, 2019
• Est. completion date: March 20, 2024

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: March 20, 2024
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients with little knowledge of the Italian language

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Paola Coluccino	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Aaronson 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 clin — View Citation

Catania 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: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the patient's Fatigue	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.	through study completion, an average of 5years
Secondary	the quality of life of patients	Quality of life of patients measured by the European Organisation for Research and Treatment of Cancer quality of life scale	through study completion, an average of 5years