Multidisciplinary Approach to Fatigue

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502224
• Other study ID #: IJB-PRINTEMPS-2022
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: September 2027

Study information

• Verified date: November 2022
• Source: Jules Bordet Institute
• Contact: Laura Polastro, MD
• Phone: +3225413279
• Email: laura.polastro[@]bordet.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 4 years
Secondary	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	At the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.