Multidisciplinary Approach to Fatigue

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Germ Cell Tumor
• Intervention / Treatment: Other: Ergospirometry

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Polastro, MD; Phone Number: +3225413279; Email: laura.polastro@bordet.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
    • Contact: Laura Polastro, MD; Phone Number: +32 (0) 2 541 3279; Email: laura.polastro@bordet.be
    • Contact: Caroline Defays; Phone Number: +32 (0) 2 541 3966; Email: caroline.defays@bordet.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Specific fatigue management program	Other: Ergospirometry; Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplasms, Germ Cell and Embryonal; Breast Neoplasms
• Other Study ID Numbers: IJB-PRINTEMPS-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No