the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Occupational Engagement in Alder Adults With Cancer - the Impact of Occupational Therapy (OCEAN-OT): a Multicenter Randomized Controlled Trial

Conditions
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Elderly Patient, Cancer, Quality of Life

Intervention / Treatment
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* Other: MCRO+Occupational therapy
* Other: MCRO without intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, controlled, superiority trial in 3 parallel arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occupational therapy intervention associated with MCRO assesment.<br>the experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention. | Other: MCRO+Occupational therapy<br>* Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.<br>* Other names: experimental arm A :Occupational therapy intervention associated with MCRO assesment;|
| Experimental: MCRO assessment without intervention<br>This experimental group 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 | Other: MCRO without intervention<br>* 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<br>* Other names: experimental arm B: MCRO assessment only;|
| No Intervention: Usual care<br>this group will have the usual cancer management care combining specific treatments and supportive care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QLQ-C30 questionnaire) | Evolution of the EORTC QLQ-C30 role functioning score at 3 months | 3 months |