the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial (OCEAN-OT)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Elderly Patient; Quality of Life; Cancer

Treatments: Other: MCRO+Occupational therapy; Other: MCRO without intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05878782

APHP230405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 3 patient groups

Occupational therapy intervention associated with MCRO assesment.

Experimental group

Description:

the experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.

Treatment:

Other: MCRO+Occupational therapy

MCRO assessment without intervention

Experimental group

Description:

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

Treatment:

Other: MCRO without intervention

Usual care

No Intervention group

Description:

this group will have the usual cancer management care combining specific treatments and supportive care.