the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

Cancer Clinical Trial

— OCEAN-OT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05878782
• Other study ID #: APHP230405
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Cynthia Engels, MD, PhD
• Phone: 06 99 24 36 80
• Email: cynthia.engels[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Elderly Patient
• Quality of Life

Intervention

Other:
• MCRO+Occupational therapy
Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QLQ-C30 questionnaire)	Evolution of the EORTC QLQ-C30 role functioning score at 3 months	3 months