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

April 7, 2025 updated by: University Hospital, Toulouse

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

geriatric population suffering from a hematological malignancy (Myelodysplasia, Leukemia of any type, Lymphoma, Myeloma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the PA program
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: Yves Rolland, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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