NCT03959813

Brief Summary

Palliative care is part of a comprehensive approach to the person, in the advanced phase of a serious illness. The purpose of this care is to relieve painful symptoms, to promote comfort and quality of life. In the context of a serious illness, the sick person is confronted with body modifications that have an impact on his body experience, that is, on his feelings and on the image that he has of his body. Psychomotricity is a paramedical discipline that focuses on body-psyche links. The psychomotor therapist is authorized to take care of psychomotor disorders, as defined in the decree of competences. These psychomotor disorders appear in connection with the evolution of the serious illness and the presence of symptoms in these patients (ex: disorders of the tonic regulation, psychomotor disharmony, disorders of the representation of the body, etc.). In palliative care, the psychomotor therapist seeks to regulate these psychomotor disorders and thus to promote a more satisfying physical experience in the patient, through the use of different bodily approaches. Several studies have shown the beneficial effects of touching and moving the body in cancer patients, but no work evaluating the effects of the psychomotor approach (involving various body mediations) on the body experience of patients with cancer in palliative situation

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

May 6, 2019

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Realization of a questionnaire, based on the patient's global and physical feeling

    questionnaire used to assess the impact of psychomotor care on the body experience of patients with advanced palliative care cancer, in both a physical and psychological dimension

    30 minutes before psychomotor care

  • Realization of a questionnaire, based on the patient's global and physical feeling

    questionnaire used to assess the impact of psychomotor care on the body experience of patients with advanced palliative care cancer, in both a physical and psychological dimension

    30 minutes after psychomotor care

Interventions

The patient will have a first psychomotricity session. It will be carried out remotely from the drug catches to avoid bias induced by their administration having effects on the symptoms studied. Before and after the session, two evaluations will be offered to the patient and performed by a nurse: * A questionnaire, based on the physical experience, * The ESAS scale will be administered to the patient to assess the importance of symptoms (pain, depression, anxiety, discomfort) During the session, a touch treatment will be offered to promote awareness of the body. Passive mobilizations at the level of the members and the axis will then be proposed, to promote the pleasure of being in motion. A touch treatment will be done again to promote relaxation. A questionnaire can be offered to the patient after 4 sessions to assess his perception of psychomotricity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients hospitalized in palliative care units

You may qualify if:

  • Age greater than or equal to 18 years
  • Man or woman
  • Subject who has agreed to participate in the research and to use the data collected for research purposes
  • Patient with solid cancer or hematological malignancy in palliative stage, that is to say a cancerous disease for which no curative treatment is no longer envisaged, with committed vital prognosis
  • Hospitalize patient in palliative care unit
  • Patient with indication of care in psychomotricity defined by the decree of competence Decree n ° 88-659 of May 6, 1988
  • Patient with a minimum score of 4 on an item or a minimum score of 4 on several cumulative items (with a minimum of 2 on at least one of the items), on the ESAS scale, among the following themes: pain, anxiety, depression, uneasy feeling

You may not qualify if:

  • Patient whose clinical condition (left to the decision of the investigator) does not allow to perform a psychomotor care and / or participate in a recorded interview (extreme fatigue, confusion, painful uncontrolled symptoms)
  • Communication difficulties, patient not speaking or not understanding French
  • Impossibility of giving the patient informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
  • Patient under guardianship, curatorship
  • Patient not affiliated to social welfare regime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 22, 2019

Study Start

September 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share