Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study

Geriatric Clinical Trial

— ACCES  

Official title:

Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study (Aging & CanCer : Exercise as a Solution)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102876
• Other study ID #: RC31/23/0409
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Geriatric
• Hematologic Neoplasms

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