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

NCT ID: NCT06102876

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-14

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Geriatric Haematologic Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves Rolland

Role: STUDY_DIRECTOR

University Hospital, Toulouse

Locations

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Chu de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/23/0409

Identifier Type: -

Identifier Source: org_study_id

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