Breast CancerNCT05502224
Multidisciplinary Approach to Fatigue
A study testing Ergospirometry in people with Breast Cancer and Germ Cell Tumor, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Breast Cancer, Germ Cell Tumor
- What is being tested?
- Ergospirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Aug 2022to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
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.
- Conditions
- Breast Cancer, Germ Cell Tumor
- Being tested
- Ergospirometry
- Medical subject headings
- Breast Neoplasms, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgospirometryOther
Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ
| Study group | Role | What they receive |
|---|---|---|
| Specific fatigue management program | Other | Not described Receives: Other: Ergospirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start19 Aug 2022
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Why it stopped: Poor Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each individual is his own control. It is therefore a longitudinal data collection.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502224
- Sponsor's protocol ID
- IJB-PRINTEMPS-2022
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT05502224
- Acronym / sponsor ID
- IJB-PRINTEMPS-2022
- Conditions
- Breast Cancer, Germ Cell Tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each individual is his own control. It is therefore a longitudinal data collection.
| Arm | Type | Receives |
|---|---|---|
| Specific fatigue management program | Other | Other: Ergospirometry |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgospirometryMaximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ | Other | Specific fatigue management program |
Primary outcome
Evaluate the feasibility of the specific fatigue management program
Time frame: 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
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: Poor Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergospirometry in people with Breast Cancer and Germ Cell Tumor, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of the specific fatigue management program (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.