Multidisciplinary Approach to Fatigue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ergospirometry.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Germ Cell Tumor. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
Overview
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
- Other Ergospirometry
Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ
Primary outcome measures
- Evaluate the feasibility of the specific fatigue management program [Time frame: Through study completion, an average of 4 years]
Secondary outcome measures (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 [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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- Institut Jules Bordet — Brussels
Identifiers
NCT: NCT05502224 · IJB-PRINTEMPS-2022