the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

NCT05878782 | Not Yet Recruiting

• 1 other identifier: APHP230405
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elderly Patient; Cancer; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life (QLQ-C30 questionnaire)

  Evolution of the EORTC QLQ-C30 role functioning score at 3 months

  3 months

Study Arms (3)

Occupational therapy intervention associated with MCRO assesment.

EXPERIMENTAL

the experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.

Other: MCRO+Occupational therapy

MCRO assessment without intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

MCRO+Occupational therapy OTHER

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

Also known as: experimental arm A :Occupational therapy intervention associated with MCRO assesment

Occupational therapy intervention associated with MCRO assesment.

MCRO without intervention OTHER

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

Also known as: experimental arm B: MCRO assessment only

MCRO assessment without intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Related Publications (1)

• Engels C, Marliac Schweitzer S, Blond O, Boulahssass R, David C, Faure H, Gaborit C, Kirscher S, Doyle Lyons K, Machado Antunes L, Morisset L, Pergolotti M, Pierro M, Pineau-Ribas C, Thamie S, Rollot-Trad F, Canoui-Poitrine F. Effects of occupational therapy on quality of life, occupational performance, and occupational satisfaction in older adults with cancer: a multicentre, pragmatic, randomized, controlled trial protocol (OCEAN-OT). BMC Geriatr. 2025 Nov 27;25(1):1064. doi: 10.1186/s12877-025-06535-y.

  PMID: 41310492 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Cynthia Engels, MD, PhD

CONTACT

06 99 24 36 80; cynthia.engels@aphp.fr

France Guyot

CONTACT

0144841751; france.guyot@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, superiority trial in 3 parallel arms

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 26, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share