Multidisciplinary Approach to Fatigue

NCT05502224 | Recruiting

• 1 other identifier: IJB-PRINTEMPS-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• 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 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

  At the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.

Study Arms (1)

Specific fatigue management program

OTHER

Other: Ergospirometry

Interventions

Ergospirometry OTHER

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

Specific fatigue management program

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type

Central Study Contacts

Laura Polastro, MD

CONTACT

+3225413279; laura.polastro@bordet.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each individual is his own control. It is therefore a longitudinal data collection.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 16, 2022
• Study Start: August 19, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

BE (1)