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the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05878782
Acronym
OCEAN-OT
Enrollment
232
Registered
2023-05-26
Start date
2023-09-01
Completion date
2026-05-01
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Elderly Patient, Quality of Life

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.

Interventions

OTHERMCRO+Occupational therapy

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

OTHERMCRO 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A randomized, controlled, superiority trial in 3 parallel arms

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life (QLQ-C30 questionnaire)3 monthsEvolution of the EORTC QLQ-C30 role functioning score at 3 months

Contacts

Primary ContactCynthia Engels, MD, PhD
cynthia.engels@aphp.fr06 99 24 36 80
Backup ContactFrance Guyot
france.guyot@aphp.fr0144841751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026