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Trial Title:
the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial
NCT ID:
NCT05878782
Condition:
Elderly Patient
Cancer
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A randomized, controlled, superiority trial in 3 parallel arms
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
MCRO+Occupational therapy
Description:
Experimental group A will combine the assessment of occupational problems (MCRO) and an
occupational therapy intervention.
Arm group label:
Occupational therapy intervention associated with MCRO assesment.
Other name:
experimental arm A :Occupational therapy intervention associated with MCRO assesment
Intervention type:
Other
Intervention name:
MCRO without intervention
Description:
Experimental group B will have only the MCRO assessment because the occupational problems
assessment alone (without intervention) could improve quality of life and occupational
performance outcomes, according to the Nielsen, 2019 study
Arm group label:
MCRO assessment without intervention
Other name:
experimental arm B: MCRO assessment only
Summary:
The purpose of this randomized controlled superiority trial is to evaluate the impact of
occupational therapy assessment and intervention on the quality of life of elderly cancer
patients.
Patients will be randomized into 3 parallel, multicenter arms with patient-reported
outcome and blinded evaluator.
- Experimental group A will combine the assessment of occupational problems (MCRO) and
an occupational therapy intervention.
- Experimental group B will have only the MCRO assessment because the occupational
problems assessment alone (without intervention) could improve quality of life and
occupational performance outcomes, according to the Nielsen, 2019 study
- Group C will have the usual cancer management care combining specific treatments and
supportive care.
Detailed description:
in order to limit the potential grading bias associated with the open-label design, the
reassessment at 3 and 6 months will be performed by a different occupational therapist
than the one who performed the initial assessment and occupational therapy intervention.
For this reason, at least two occupational therapists per geographic area of the centers
that include the patients will be included in the project.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥ 70 years;
- Colorectal, breast, prostate or lung cancer;
- Between 1 and 3 months after the start of cancer treatment depending on the type of
treatment (Surgery and/or systemic treatment and/or radiotherapy);
- For curative purposes;
- Affiliated to a social security scheme;
- Living at home;
- Agreeing to participate in the research and having given a free, informed and signed
consent
Exclusion Criteria:
- person caring for a patient meeting the above criteria;
- Living with the patient;
- Agreeing to participate in the research and having given free, informed and signed
consent
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2023
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05878782
