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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occupational therapy intervention associated with MCRO assesment. | Experimental | the experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention. |
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| MCRO assessment without intervention | Experimental | 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 |
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| Usual care | No Intervention | this group will have the usual cancer management care combining specific treatments and supportive care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCRO+Occupational therapy | Other | Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QLQ-C30 questionnaire) | Evolution of the EORTC QLQ-C30 role functioning score at 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Engels, MD, PhD | Contact | 06 99 24 36 80 | 33 | cynthia.engels@aphp.fr |
| France Guyot | Contact | 0144841751 | 33 | france.guyot@aphp.fr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41310492 | Derived | Engels C, Marliac Schweitzer S, Blond O, Boulahssass R, David C, Faure H, Gaborit C, Kirscher S, Doyle Lyons K, Machado Antunes L, Morisset L, Pergolotti M, Pierro M, Pineau-Ribas C, Thamie S, Rollot-Trad F, Canoui-Poitrine F. Effects of occupational therapy on quality of life, occupational performance, and occupational satisfaction in older adults with cancer: a multicentre, pragmatic, randomized, controlled trial protocol (OCEAN-OT). BMC Geriatr. 2025 Nov 27;25(1):1064. doi: 10.1186/s12877-025-06535-y. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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A randomized, controlled, superiority trial in 3 parallel arms
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| MCRO without intervention | Other | 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 |
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