The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor, (Fatigue-ONCO)

February 27, 2024 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40139
        • Paola Coluccino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the patient's Fatigue
Time Frame: 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.
through study completion, an average of 5years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the quality of life of patients
Time Frame: 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
through study completion, an average of 5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2019

Primary Completion (Actual)

August 20, 2022

Study Completion (Estimated)

March 20, 2024

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fatigue-ONCO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on assessment scales (BFI, QLQ, TESS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe