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.
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
- Conditions the study is for
- Management of Oral Care and Cancer in Palliative Situation
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 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.
Proportion of patients with an improvement of 10% of the buccal state
Measured: up to day 15
Secondary outcomes (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.
- First posted5 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Oral Care and Cancer in Palliative SituationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Marie-Christine GRACH, MD, Principal investigator, Centre François Baclesse
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation
- ClinicalTrials.gov ID
- NCT02208908
- Acronym / sponsor ID
- BBC3
- Keywords
- Oral care, cancer, palliative, training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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 study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with cancer hospitalize inpalliative situation | – | Other: Evaluation of the oral conditionand proper careAn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cancer hospitalize inpalliative situation
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Evaluation of the oral conditionand proper careAn 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. | Other | Patient with cancer hospitalize inpalliative situation |
Primary outcome
Proportion of patients with an improvement of 10% of the buccal state
Time frame: up to day 15
1 secondary outcome
The quality and adequacy of the prescription (non-drug and / or drug attitudes) to record oral
Time frame: Day 2 and 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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.
Marie-Christine GRACH, MD principal investigator
Centre François Baclesse
5 sites in 1 country: see every site and its status.
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.