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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Cancer; Elderly Patient
• Intervention / Treatment: Other: MCRO+Occupational therapy; Other: MCRO without intervention

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 Type: Interventional
• Enrollment (Estimated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: France Guyot; Phone Number: 33 0144841751; Email: france.guyot@aphp.fr
• Study Contact Backup: Name: Cynthia Engels, MD, PhD; Phone Number: 33 06 99 24 36 80; Email: cynthia.engels@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: MCRO+Occupational therapy; Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.; Other Names: experimental arm A :Occupational therapy intervention associated with MCRO assesment
Experimental: 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	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; Other Names: experimental arm B: MCRO assessment only
No Intervention: Usual care; this group will have the usual cancer management care combining specific treatments and supportive care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QLQ-C30 questionnaire)	Evolution of the EORTC QLQ-C30 role functioning score at 3 months	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: APHP230405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No