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NCT05878782 | Not yet recruiting | Elderly Patient


the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial
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.

Condition or disease

Elderly Patient

Cancer

Quality of Life

Intervention/treatment

MCRO+Occupational therapy

MCRO without intervention

Phase

Not Applicable

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
Estimated Enrollment : 232 participants
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Occupational Engagement in Alder Adults With Cancer - the Impact of Occupational Therapy (OCEAN-OT): a Multicenter Randomized Controlled Trial
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : May 1, 2026
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.

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

No Intervention: Usual care

this group will have the usual cancer management care combining specific treatments and supportive care.

Ages Eligible for Study: 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

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the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

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