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NCT Number: NCT05502224

Multidisciplinary Approach to Fatigue

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Germ Cell Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ergospirometry

Other

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

Primary outcomes

  1. 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

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

    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.

    Numerical Rating Scale (NRS) for fatigue

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Polastro, MD

CONTACT

[email protected]

+3225413279

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 16, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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