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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06102876
Other study ID # RC31/23/0409
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2023
Est. completion date March 31, 2025

Study information

Verified date December 2023
Source University Hospital, Toulouse
Contact YVES ROLLAND
Phone (0)5 61 77 21 00
Email rolland.y@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 69
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical activity (PA) program
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.

Locations

Country Name City State
France Chu de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the PA program PA program is considered feasible if at least 50% of them complete at least 70% of the prescribed sessions. Adherence is recorded in a logbook (every day), during the usual follow-up at the hospital (every month) and during telephone follow-up (weeks 1, 2, 4, 6, 9, 12, 16, 20, et 24). 6 months
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