CClinicalTrials.gg
RecruitingNCT05502224Updated Nov 8, 2022

Multidisciplinary Approach to Fatigue

An interventional study of Ergospirometry in Breast Cancer and Germ Cell Tumor, sponsored by Jules Bordet Institute. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Jules Bordet Institute · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 39 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Germ Cell Tumor
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Specific fatigue management program

    Other: Ergospirometry

Interventions

  • OtherErgospirometry

    Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, an average of 4 years

Secondary outcomes

  1. 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

    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.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05502224
Lead sponsor
Jules Bordet Institute
Responsible party
Sponsor
First posted
Aug 16, 2022
Start date
Aug 19, 2022
Primary completion
Sep 2026 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 8, 2022

Study contacts

Laura Polastro, MD
Contact
laura.polastro@bordet.be
+3225413279

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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