NCT05878782

the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Elderly Patient
• Cancer
• Quality of Life

Interventions

Type	Name	Description
OTHER	MCRO+Occupational therapy	Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
OTHER	MCRO without 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

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-05-26
• Last updated: 2023-05-26