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Multidisciplinary Approach to Fatigue

Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05502224
Enrollment
50
Registered
2022-08-16
Start date
2022-08-19
Completion date
2027-09-30
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Germ Cell Tumor

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.

Interventions

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

Sponsors

Jules Bordet Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Each individual is his own control. It is therefore a longitudinal data collection.

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the feasibility of the specific fatigue management programThrough study completion, an average of 4 yearsRate 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

MeasureTime frameDescription
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 programAt the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.Numerical Rating Scale (NRS) for fatigue

Countries

Belgium

Contacts

Primary ContactLaura Polastro, MD
laura.polastro@bordet.be+3225413279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026