Elderly PatientOCEAN-OTNCT05878782
the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial
A study testing MCRO+Occupational therapy and MCRO without intervention in people with Elderly Patient and Cancer, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly Patient, Cancer, Quality of Life
- What is being tested?
- MCRO+Occupational therapy and MCRO without intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Occupational Engagement in Alder Adults With Cancer - the Impact of Occupational Therapy (OCEAN-OT): a Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Elderly Patient, Cancer, Quality of Life
- Being tested
- MCRO+Occupational therapy, MCRO without intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCRO+Occupational therapyOther
Also called experimental arm A :Occupational therapy intervention associated with MCRO assesment
Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
MCRO without interventionOther
Also called experimental arm B: MCRO assessment only
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: MCRO without intervention |
| Usual care | No intervention | this group will have the usual cancer management care combining specific treatments and supportive care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QLQ-C30 questionnaire)
Evolution of the EORTC QLQ-C30 role functioning score at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly PatientStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, superiority trial in 3 parallel arms
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878782
- Sponsor's protocol ID
- APHP230405
- Acronym
- OCEAN-OT
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41310492
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Engagement in Alder Adults With Cancer - the Impact of Occupational Therapy (OCEAN-OT): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05878782
- Acronym / sponsor ID
- OCEAN-OT / APHP230405
- Conditions
- Elderly Patient, Cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized, controlled, superiority trial in 3 parallel arms
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy intervention associated with MCRO assesment. | Experimental | Other: MCRO+Occupational therapythe experimental care of this group will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention. |
| MCRO assessment without intervention | Experimental | Other: MCRO without interventionThis 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 |
| Usual care | No intervention | –this group will have the usual cancer management care combining specific treatments and supportive care. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥ 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCRO+Occupational therapyAlso: experimental arm A :Occupational therapy intervention associated with MCRO assesmentExperimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention. | Other | Occupational therapy intervention associated with MCRO assesment. |
| MCRO without interventionAlso: experimental arm B: MCRO assessment onlyExperimental 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 | Other | MCRO assessment without intervention |
Primary outcome
Quality of life (QLQ-C30 questionnaire)
Time frame: 3 months
Evolution of the EORTC QLQ-C30 role functioning score at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 41310492Engels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing MCRO+Occupational therapy and MCRO without intervention in people with Elderly Patient and Cancer, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Engels, MD, PhD (06 99 24 36 80 ext. 33, cynthia.engels@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QLQ-C30 questionnaire) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.