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Multidisciplinary Approach to Fatigue

Primary Purpose

Breast Cancer, Germ Cell Tumor

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ergospirometry
Sponsored by
Jules Bordet Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules BordetRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Specific fatigue management program

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2022
Last Updated
November 7, 2022
Sponsor
Jules Bordet Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05502224
Brief Title
Multidisciplinary Approach to Fatigue
Official Title
Pilot Project for the Implementation of an Integrated Multidisciplinary Follow-up for Young Patients With Breast Cancer or Germ Cell Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Germ Cell Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each individual is his own control. It is therefore a longitudinal data collection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Specific fatigue management program
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Ergospirometry
Intervention Description
Maximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ
Primary Outcome Measure Information:
Title
Evaluate the feasibility of the specific fatigue management program
Description
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
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
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
Description
Numerical Rating Scale (NRS) for fatigue
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Polastro, MD
Phone
+3225413279
Email
laura.polastro@bordet.be
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Polastro, MD
Phone
+32 (0) 2 541 3279
Email
laura.polastro@bordet.be
First Name & Middle Initial & Last Name & Degree
Caroline Defays
Phone
+32 (0) 2 541 3966
Email
caroline.defays@bordet.be

12. IPD Sharing Statement

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Multidisciplinary Approach to Fatigue

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