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the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

NCT05878782 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2023-05-26

No results posted yet for this study

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.

Conditions

  • Elderly Patient
  • Cancer
  • Quality of Life

Interventions

OTHER

MCRO+Occupational therapy

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

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-05-01
Completion
2026-05-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05878782 on ClinicalTrials.gov