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

NCT04104750 | Completed

• 1 other identifier: Fatigue-ONCO
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue Syndrome, Chronic; Bone Tumor; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the quality of life of patients

  through study completion, an average of 5years

Interventions

assessment scales (BFI, QLQ, TESS) OTHER

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.

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients belonging to the Chemotherapy ward will be recruited consecutively for a new antiblastic treatment protocol. The process of informing and collecting the participants' consent will take place during the first admission in which intravenous administration of the chemotherapy will be started

You may qualify if:

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

You may not qualify if:

• patients with little knowledge of the Italian language

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Paola Coluccino

Bologna, BO, 40139, Italy

Location

Related Publications (3)

• 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 clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 RESULT

• 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: 10.1007/s00520-012-1539-z. Epub 2012 Jul 13.

  PMID: 22790224 RESULT

• Morri 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 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Bone Neoplasms

Interventions

TES

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Bone Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 26, 2019
• Study Start: July 26, 2019
• Primary Completion: August 20, 2022
• Study Completion: March 20, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)