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

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Unknown status
CT.gov ID
NCT04104750
Collaborator
(none)
183
1
36.8
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: assessment scales (BFI, QLQ, TESS)

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
183 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor, Undergoing Chemotherapy Treatment and Possible Predictive Factors
Actual Study Start Date :
Jul 26, 2019
Anticipated Primary Completion Date :
Aug 20, 2022
Anticipated Study Completion Date :
Aug 20, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients diagnosed with bone tumors who start a new chemotherapy treatment protocol
Exclusion Criteria:
  • patients with little knowledge of the Italian language

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paola Coluccino Bologna BO Italy 40139

Sponsors and Collaborators

  • Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Paola Coluccino, Nurse coordinator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT04104750
Other Study ID Numbers:
  • Fatigue-ONCO
First Posted:
Sep 26, 2019
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2019