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Trial Title:
Multidisciplinary Approach to Fatigue
NCT ID:
NCT05502224
Condition:
Breast Cancer
Germ Cell Tumor
Conditions: Official terms:
Breast Neoplasms
Neoplasms, Germ Cell and Embryonal
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Each individual is his own control. It is therefore a longitudinal data collection.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Ergospirometry
Description:
Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's
RQ
Arm group label:
Specific fatigue management program
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Laura Polastro, MD
Phone:
+32 (0) 2 541 3279
Email:
laura.polastro@bordet.be
Contact backup:
Last name:
Caroline Defays
Phone:
+32 (0) 2 541 3966
Email:
caroline.defays@bordet.be
Start date:
August 19, 2022
Completion date:
September 2027
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05502224
