Multidisciplinary Approach to Fatigue

Sponsor
Jules Bordet Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05502224
Collaborator
(none)
50
1
1
61
0.8

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: Ergospirometry
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Each individual is his own control. It is therefore a longitudinal data collection.Each individual is his own control. It is therefore a longitudinal data collection.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Specific fatigue management program

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate the feasibility of the specific fatigue management program [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 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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Jules Bordet Brussels Belgium 1070

Sponsors and Collaborators

  • Jules Bordet Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT05502224
Other Study ID Numbers:
  • IJB-PRINTEMPS-2022
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022