Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Elderly Patient | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MCRO+Occupational therapy | Other | — | UNRESOLVED |
| MCRO without intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Occupational therapy intervention associated with MCRO assesment.
- description
- the experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
- interventionNames
- Other: MCRO+Occupational therapy
- type
- EXPERIMENTAL
- label
- MCRO assessment without intervention
- description
- 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
- interventionNames
- Other: MCRO without intervention
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEngels 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