the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

NCT ID: NCT05878782

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Occupational therapy intervention associated with MCRO assesment.

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

Group Type: EXPERIMENTAL

MCRO+Occupational therapy

Intervention Type: OTHER

Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.

MCRO assessment without intervention

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

Group Type: EXPERIMENTAL

MCRO without intervention

Intervention Type: 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

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MCRO+Occupational therapy

Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

experimental arm A :Occupational therapy intervention associated with MCRO assesment; experimental arm B: MCRO assessment only

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Cynthia Engels, MD, PhD

Role: CONTACT

cynthia.engels@aphp.fr

06 99 24 36 80 ext. 33

France Guyot

Role: CONTACT

france.guyot@aphp.fr

0144841751 ext. 33

Other Identifiers

APHP230405

Identifier Type: -

Identifier Source: org_study_id