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OCEAN-OT: the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05878782
Collaborator
(none)
232
Enrollment
3
Arms
32
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Other: MCRO+Occupational therapy
  • Other: MCRO without intervention
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
232 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized, controlled, superiority trial in 3 parallel armsA randomized, controlled, superiority trial in 3 parallel arms
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
May 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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.

Other: MCRO+Occupational therapy
Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
Other Names:
  • experimental arm A :Occupational therapy intervention associated with MCRO assesment

    		•
    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

    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
    Other Names:
  • experimental arm B: MCRO assessment only

    		•
    No Intervention: Usual care

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

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life (QLQ-C30 questionnaire) [3 months]

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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05878782
    Other Study ID Numbers:
    • APHP230405
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 26, 2023