Multidisciplinary Approach to Fatigue

Not Applicable

Recruiting

• Conditions: Breast Cancer; Germ Cell Tumor
• Interventions: Other: Ergospirometry

• Registration Number: NCT05502224
• Lead Sponsor: Jules Bordet Institute

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.

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-16
• Study Start: 2022-08-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Specific fatigue management program	Ergospirometry	-

Primary Outcome Measures

Name	Time	Method
Evaluate the feasibility of the specific fatigue management program	Through study completion, an average of 4 years	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

Name	Time	Method
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	At 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

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium