Fatigue Syndrome, ChronicFatigue-ONCONCT04104750
The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor,
An observational study of Fatigue Syndrome, Chronic and Bone Tumor, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Fatigue Syndrome, Chronic, Bone Tumor, Quality of Life
- What is being tested?
- assessment scales (BFI, QLQ, TESS)
- How many people
- 155 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jul 2019to 20 Mar 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- patients diagnosed with bone tumors who start a new chemotherapy treatment protocol
Who cannot join
- patients with little knowledge of the Italian language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- assessment scales (BFI, QLQ, TESS)
- Medical subject headings
- Fatigue Syndrome, Chronic, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5years
Secondary outcomes (1)
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
Measured: through study completion, an average of 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start26 Jul 2019
- Primary completion20 Aug 2022
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104750
- Sponsor's protocol ID
- Fatigue-ONCO
- Acronym
- Fatigue-ONCO
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2019
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8433390Catania 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.
PubMed 22790224Morri 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.
PubMed 39577033
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor, Undergoing Chemotherapy Treatment and Possible Predictive Factors
- ClinicalTrials.gov ID
- NCT04104750
- Acronym / sponsor ID
- Fatigue-ONCO / Fatigue-ONCO
- Conditions
- Fatigue Syndrome, Chronic, Bone Tumor, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients diagnosed with bone tumors who start a new chemotherapy treatment protocol
Key exclusion criteria (1 listed)
- patients with little knowledge of the Italian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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.
1 secondary outcome
the quality of life of patients
Time frame: through study completion, an average of 5years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Results publication: PubMed 8433390Aaronson 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.
- Results publication: PubMed 22790224Catania 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.
- Derived from this study: PubMed 39577033Morri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue Syndrome, Chronic and Bone Tumor, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the patient's Fatigue (time frame: through study completion, an average of 5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104750, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.