the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Elderly Patient; Quality of Life; Cancer
• Interventions: Other: MCRO without intervention; Other: MCRO+Occupational therapy

• Registration Number: NCT05878782
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26
• Study Start: 2023-09-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 232

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCRO assessment without intervention	MCRO 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
Occupational therapy intervention associated with MCRO assesment.	MCRO+Occupational therapy	the experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.

Primary Outcome Measures

Name	Time	Method
Quality of life (QLQ-C30 questionnaire)	3 months	Evolution of the EORTC QLQ-C30 role functioning score at 3 months