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Management of Oral Care and Cancer in Palliative SituationNCT02208908

Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation

An observational study of Management of Oral Care and Cancer in Palliative Situation, run by Centre Francois Baclesse at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Evaluation of the oral conditionand proper care
Type of treatment
Pill or oral medicine
How many people
280 participants
Where
5 sitesFrance
Study dates
Apr 2014to Jun 2015
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with cancer hospitalize inpalliative situation

Who may be able to join

  • Patient aged over 18 years with cancer and palliative hospital situation
  • Patient able to communicate with the nursing staff;
  • Patient able to understand the meaning of the questions;
  • Patients whose length of stay is at least 5 days
  • Patients whose life expectancy is greater than or equal to three weeks;
  • Patients who have given their written consent to the study participation.

Who cannot join

  • Patient refusing to make the clinical assessment;
  • Patient not giving their consent for participation;
  • Patient unable to communicate with the nursing staff;
  • Patient not proficient in the French language;
  • Patient suffering from cognitive deficits.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites
  • Institut de Cancérologie de l'Ouest

    Angers, 49933

  • Centre François Baclesse

    Caen, 14076

  • Centre Oscar Lambret

    Lille, 59020

  • Institut de Cancérologie de l'Ouest

    Nantes, 44805

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

About this study

The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation.

Read the detailed description

According to the French support and palliative care (RFS) Company, palliative care are active in a holistic approach to the person with a serious illness, progressive or terminal. Their goal is to relieve physical symptoms and other pain and take into account the psychological, social and spiritual suffering.

He consensus among caregivers to recognize the importance and maintaining good oral hygiene for patients treated for cancer at all ages of life, home and in hospital, and consider that the oral hygiene is an integral part of nursing, toilet and contributes to the health of patients. This is primarily a comfort for the person to have a healthy mouth, healthy with a clean mouth, but also a tool that meets all its features.

The feeding, respiration and communication are three closely related to the proper functioning of the oral cavity needs. Furthermore, cancer, various treatments, age are possible disturbances oral integrity. The nurse helped the caregiver has upstream of care, the role of counseling and prevention. However, a review of the oral and / or the establishment of procedures support oral hygiene status are largely neglected despite the existence of published recommendations. This is particularly related to lack of information provided and continuing education offered to carers and the lack of written procedures. Moreover, the limited literature on the subject limit the possibility of initiatives, the establishment of a procedure before relying on evidence-based practice. Measure 43 Cancer Plan I and the establishment of mobile units or palliative care teams and management of pain in Residential Care (especially CHU and Centres for the Fight Against Cancer [PBC] ) is an opportunity to implement an audit action.

This project is part of a research program in several steps. From November 2010 to August 2011, 260 patients (107 hommes/153 women), median age 64 years (19-88 years) were included. J2, a healthy mouth, moderately (dry mouth and / or dirty) or severely (fungal mouth and / or painful ulcerated and / or hemorrhagic) was altered respectively observed for 61 (23.5%), 139 (53.5%) and 60 (23.0%) patients. Traceability of this oral assessment is found in 10% of cases. The exit assessment was performed in 184 patients (46 deaths, 30 non-assessed), including 129 with a delay ≥ 5 days between J2 and output. The mouth on the output shows a healthy mouth, moderately and severely impaired in 33 (26%), 70 (54%) and 26 (20%) of these 129 patients, respectively. Thus, 27 (21%) patients showed deterioration in their oral condition during hospitalization: 13/31 (42%) for patients with a healthy mouth to J2 and 14/72 (19%) for those with a mouth moderately altered to J2. In contrast, 28/129 (22%) patients, including 13/72 (18%) and 15/26 (58%) respectively had a mouth moderately and severely impaired the initial assessment have improved access to oral output state .

Following this audit action, a tool Medical Assessment mouth has been prepared in collaboration with health care teams participating as well as recommendations for management of each type of mouth (concerning both hygiene as drug and non-drug measures), in agreement with those of learned societies, a plan of care by type of mouth care.

An inter centers presenting the results of the first stage (inventory) and definition of the training plan was held in March 2013 in the presence, for each center, doctor, and nurse care manager and / or scope of health involved in palliative care and research program. The purpose of this meeting was to present the evaluation grid of mouth and recommendations developed state care and the plan and tools for training healthcare teams on site.

From May to September 2013, personnel, formed during this meeting, provide training for paramedical and medical teams of their establishment.

The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation.

Expected results We hope that the appropriate training of health care teams allow all patients during their hospitalization benefit systematically evaluate the oral condition, the implementation of actions consistent with the recommendations and thus an improvement the care of their oral condition.

Ultimately, it is hoped that the management of the oral condition falls within the overall care of the patient.

Being tested
Evaluation of the oral conditionand proper care
Keywords
Oral care, cancer, palliative, training
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of the oral conditionand proper careOther

    An accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers.

Study groups in NCT02208908
Study groupRoleWhat they receive
Patient with cancer hospitalize inpalliative situationAn accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers. An assessment of the traceability of clinical assessment and appropriate treatment prescribed or will be conducted on day 3 and repeated the day of the release of hospitalization (or day 15) from information recorded in the patient record
Receives: Other: Evaluation of the oral conditionand proper care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with an improvement of 10% of the buccal state

    Measured: up to day 15

Secondary outcomes (1)
  1. The quality and adequacy of the prescription (non-drug and / or drug attitudes) to record oral

    Measured: Day 2 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02208908
Sponsor's protocol ID
BBC3
Status last verified
Aug 2015
First submitted
4 Aug 2014
Last updated
6 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Management of Oral Care and Cancer in Palliative Situation, run by Centre Francois Baclesse at 5 sites in France.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with an improvement of 10% of the buccal state (time frame: up to day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Aug 2015.

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