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

August 5, 2015 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Institut de cancerologie de l'ouest
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Nantes, France, 44805
        • Institut de cancerologie de l'ouest
      • Rouen, France, 76038
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with cancer hospitalize inpalliative situation

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient with cancer hospitalize inpalliative situation

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.

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
Other: Evaluation of the oral conditionand proper care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with an improvement of 10% of the buccal state
Time Frame: up to day 15
up to day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The quality and adequacy of the prescription (non-drug and / or drug attitudes) to record oral
Time Frame: Day 2 and 15
Day 2 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Francois Baclesse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ligue contre le cancer, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Christine GRACH, MD, Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBC3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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