Multidisciplinary Approach to Fatigue
Primary Purpose
Breast Cancer, Germ Cell Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ergospirometry
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 39 years at the time of signing the informed consent
- Patient who speaks and understands French
- Signed study informed consent form obtained prior to any study related procedures
- At minimum, a moderate (>3) fatigue level according to the Standard Rating Scale (NRS) 1 month after completion of acute treatment; as measured at the Survivorship of the standard program
- Patient with either: curative breast cancer (AJCC stage I-II-III) or a germ cell tumor
Exclusion Criteria:
- Refusal to participate in the study
- Patient having chosen to participate in another psychosocial intervention study for the duration of the study.
- Patients with AJCC stage IV breast cancer
Sites / Locations
- Institut Jules BordetRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Specific fatigue management program
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the feasibility of the specific fatigue management program
Rate of participation The program will be considered feasible for a given patient if he/she participates in a minimum of 70% of the 70% of the sessions/activities defined in their particular program
Secondary Outcome Measures
The measurement of the evolution of the intensity of residual fatigue in the months following acute cancer treatment(s) before and after the specific fatigue management program
Numerical Rating Scale (NRS) for fatigue
Full Information
NCT ID
NCT05502224
First Posted
August 11, 2022
Last Updated
November 7, 2022
Sponsor
Jules Bordet Institute
1. Study Identification
Unique Protocol Identification Number
NCT05502224
Brief Title
Multidisciplinary Approach to Fatigue
Official Title
Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective longitudinal, single-center, non-randomized study for the implementation of an integrated multidisciplinary fatigue follow-up for young patients with breast cancer or germ cell tumour
Detailed Description
Each patient will receive a full evaluation by a multidisciplinary evaluation by a multidisciplinary team during one day. This evaluation will take place between 1 and 3 months after the end of "acute" treatments. The team is composed of an oncologist, a psychologist, a physiotherapist, a dietician and a nurse-coach. The goal of this comprehensive evaluation is to :
to detect organic or psychological factors (severe depression,...) contributing to fatigue.
to evaluate in detail the impact of fatigue on the patient's daily life.
to evaluate the patient's level of physical activity in order to propose an adequate and and personalized management. During this evaluation, the patient will be asked to discuss which aspects of his or her daily life he or she would like to improve as a priority. At the end of this complete evaluation, each patient's case will be will be discussed in a multidisciplinary meeting with all the people involved in the program in order to propose a detailed and personalized treatment plan.
This plan will be explained in detail to the patient by the nurse-coach who will organize and coordinate the patient's care. The patient will receive the detailed management plan in writing.
The patient will receive the detailed management plan in writing, which will also be communicated to the patient's treating physicians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Germ Cell Tumor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each individual is his own control. It is therefore a longitudinal data collection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specific fatigue management program
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Ergospirometry
Intervention Description
Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ
Primary Outcome Measure Information:
Title
Evaluate the feasibility of the specific fatigue management program
Description
Rate of participation The program will be considered feasible for a given patient if he/she participates in a minimum of 70% of the 70% of the sessions/activities defined in their particular program
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
The measurement of the evolution of the intensity of residual fatigue in the months following acute cancer treatment(s) before and after the specific fatigue management program
Description
Numerical Rating Scale (NRS) for fatigue
Time Frame
At the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 39 years at the time of signing the informed consent
Patient who speaks and understands French
Signed study informed consent form obtained prior to any study related procedures
At minimum, a moderate (>3) fatigue level according to the Standard Rating Scale (NRS) 1 month after completion of acute treatment; as measured at the Survivorship of the standard program
Patient with either: curative breast cancer (AJCC stage I-II-III) or a germ cell tumor
Exclusion Criteria:
Refusal to participate in the study
Patient having chosen to participate in another psychosocial intervention study for the duration of the study.
Patients with AJCC stage IV breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Polastro, MD
Phone
+3225413279
Email
laura.polastro@bordet.be
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Polastro, MD
Phone
+32 (0) 2 541 3279
Email
laura.polastro@bordet.be
First Name & Middle Initial & Last Name & Degree
Caroline Defays
Phone
+32 (0) 2 541 3966
Email
caroline.defays@bordet.be
12. IPD Sharing Statement
Learn more about this trial
Multidisciplinary Approach to Fatigue
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