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Trial Title:
Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study
NCT ID:
NCT06102876
Condition:
Geriatric
Haematologic Neoplasm
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
older adults
cancer
physical activity
deconditioning
sedentarity
aging-well
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Physical activity (PA) program
Description:
The PA program is specific for each patient according to their mobility profile assessed
using a decision tree comprising 3 tests: 1) the number of repetitions in the 30-second
sit-to-stand test, 2) the score in the Short Physical Performance Battery (SPPB) test and
3) grip strength. The PA program has to be performed once daily.
Summary:
The aim of this study is to implement a simple and unsupervised home-based physical
activity (PA) program for cancer patients in 2 oncogeriatric units in Toulouse Hospital
(day hospital and week hospital).
Detailed description:
Cancer treatments can cause side effects such as fatigue and reduced muscle function.
Studies have shown the benefits of physical activity, including reduced fatigue and
improved quality of life. Moreover, PA is often recommended for cancer survivors rather
than patients undergoing treatment. It is essential to develop adapted, unsupervised,
home-based PA programs to ensure access to PA for all cancer patients, particularly those
living in rural areas or who have difficulty accessing healthcare. The PA program CREATE
is a simple, unsupervised PA program based on patients' functional capacities. Depending
on the patient's functional capacity, one of 7 PA programs will be prescribed by the
doctor. The patient must perform the program independently for 6 months. Telephone
follow-ups (weeks 1, 2, 4, 6, 9, 12, 16, 20, et 24) as well as a monthly in-person
follow-up visit will be made to adjust the prescription.
Criteria for eligibility:
Study pop:
geriatric population suffering from a hematological malignancy (Myelodysplasia, Leukemia
of any type, Lymphoma, Myeloma
Sampling method:
Non-Probability Sample
Criteria:
inclusion criteria:
- suffering from a hematological malignancy (Myelodysplasia, Leukemia of any type,
Lymphoma, Myeloma)
- patient affiliated to a social security insurance
- Patient undergoing or scheduled chemotherapy (< 3 months) and/or immunotherapy
and/or targeted therapy.
Exclusion criteria:
- Life expectancy estimated at less than 3 months by the unit doctor;
- Cognitive impairment (not allowing comprehension of the physical activity program
and research project) defined by Mini-Mental State Examination (MMSE) <20/30;
- Patient included in a clinical trial that potentially interferes with the study
objective (geriatric interventional study, early drug study, study modifying the
patient's lifestyle habits).;
- Acute health problem (fever, severe anemia, intense pain, etc.) limiting the
possibility of involvement in the program;
- Contraindication to physical activity;
- Patient under legal protection (guardianship or curatorship or safeguard of
justice);
- Refusal of patient or primary caregiver to participate.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu de Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
YVES ROLLAND
Phone:
(0)5 61 77 21 00
Phone ext:
+33
Email:
rolland.y@chu-toulouse.fr
Investigator:
Last name:
Yves Rolland
Email:
Principal Investigator
Start date:
November 14, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
University Hospital, Toulouse
Agency class:
Other
Source:
University Hospital, Toulouse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102876
