Clinical trial NCT05502224: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Germ Cell Tumor
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each individual is his own control. It is therefore a longitudinal data collection.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluate the feasibility of the specific fatigue management program
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: 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
timeFrame: At the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
References: