CancerNCT02207543
Assessment of Patient Satisfaction in Palliative Cancer When They Return Home After Hospitalization in Palliative Care
A study testing Medical telephone contact in people with Cancer and Palliative Care, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The proposed work is part of a multidisciplinary approach to continuity of care in the particular context of the palliative phase of cancer. In conducting this study, we would like to characterize, at the regional level, satisfaction with the care of patients and their families in their care home situations palliative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Palliative Care, Home
- What is being tested?
- Medical telephone contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Mar 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patient (s) age (s) of 18 or more;
- Patient (s) reached (s) from cancer wholly palliative phase (estimated life expectancy of less than 3 months) in the judgment of the investigator;
- Patient (s) hospital (s) in palliative care and candidate for a return home;
- Patient (s) able to communicate with the investigator or his representative;
- Patient (s) have received clear information on the diagnosis and prognosis of their disease;
- Free and informed consent signed.
Who cannot join
- Patient (s) under guardianship or unable to give informed consent;
- Patient (s) whose cognitive functions can not be questioned.
- Patient (s) whose psychological distress does not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The proposed work is part of a multidisciplinary approach to continuity of care in the particular context of the palliative phase of cancer. In conducting this study, we would like to characterize, at the regional level, satisfaction with the care of patients and their families in their care home situations palliative cancer. This evaluation will be based on questionnaires adapted versions in French language satisfaction questionnaires recently validated for patients in palliative situation and supported home care.
It will also identify the challenges faced by both patients, caregivers attending physicians.
The evaluation of these elements is a prerequisite to propose ways of improving at a hospital palliative care for output relay and anticipate the coordination of care for optimal care of the patient at home, to meet the expectations of different stakeholders, or even prevent certain readmissions "avoidable".
Read the detailed description
- Background and rationale of the research project Palliative care is defined, according to the French Society for Support and Palliative Care as acute care delivered in a comprehensive approach to the person with a serious illness, progressive or terminal. Their goal is to relieve physical pain and other symptoms, but also take into account the psychological, social and spiritual suffering. According to this definition, palliative care is interdisciplinary, cater to the patient as a person and his family, at home or in an institution and strive to preserve the best possible quality of life until death.
Very few studies on the quality of life for patients at end of life were conducted in France. Among them, the TRAPADO study is a prospective study to evaluate the quality of care, quality of life and impact on the environment in three parallel cohorts of cancer patients in palliative phase according to their choice of inpatient traditional in palliative care or home. The interim analysis of this study, was published in 2006 in the journal Bulletin of cancer: patients expressed a priority choice for the home; there was a marked alteration of the overall quality of life, as measured by the EORTC-QLQC30, no statistically significant difference between home and hospital; anxiety level was higher in the hospital. Relatives were satisfied with the care of the patient with a good perception of the family fabric and expressed a lower level of psychosocial distress at home. Nevertheless, the terminal readmissions were common with a large majority of hospital deaths.
More recently, Régis Aubry, in the framework of the National Observatory on End of Life (ONFV), has conducted an extensive field survey, published in March 2013, up to the caregivers who meet together near home but also health professionals involved in supporting patients at end of life. The report of this work highlights the importance of developing palliative care in the home including the intervention of specialized teams and coordination of teams working at home.
Indeed, in France, while 81% of the French would "spend their last moments at home" (FIFG, 2010), only 25.5% of deaths occur at home (ONFV, 2012).
Faced with this reality, we were asked to know what elements can explain this discrepancy between this reality and the desire of patients. This issue was the subject of a preliminary study, conducted in 2013 in Lower Normandy region. We chose to study the management of patients with cancer in palliative home situation by their GP after hospitalization Identified beds Palliative Care (LISP) Centre François Baclesse Caen: 19 of the 23 patients assessed, have expressed their willingness on the place of death to their GP, wanted to die at home. Nearly half (48%) of patients in our study died in the hospital. GPs interviewed reported that maintaining the homes of these patients had been facilitated by the relief of distressing symptoms and the establishment of aid.
This finding demonstrates that the GP can often not only coordinate the sometimes complex palliative situations, at home and that the intervention of specialized teams, interdisciplinary, is fundamental to maintaining a home in the best possible conditions.
But what about the patient felt about his quality of life at home? After collecting feedback from GPs Lower Normandy, we would like to continue this work. In this context, we propose a pilot study, single-center, to assess the satisfaction of patients and their families in home support palliative phase of cancer.
- Emerging nature of research topics covered: The proposed work is part of a multidisciplinary approach to continuity of care in the particular context of the palliative phase of cancer. In conducting this study, we would like to characterize, at the regional level, satisfaction with the care of patients and their families in their care home situations palliative cancer. This evaluation will be based on questionnaires adapted versions in French language satisfaction questionnaires recently validated for patients in palliative situation and supported home care.
It will also identify the challenges faced by both patients, caregivers attending physicians.
The evaluation of these elements is a prerequisite to propose ways of improving at a hospital palliative care for output relay and anticipate the coordination of care for optimal care of the patient at home, to meet the expectations of different stakeholders, or even prevent certain readmissions "avoidable".
- Degree of risk-taking and innovative scientific approach: The situation at the end of life patient palliative situation of cancer remains a research context underdeveloped. This study is based on the involvement of patients and their caregivers, at this stage of the disease to assess their satisfaction with care when returning home after a hospital palliative care. It proposes indeed used for this self-administered to patients and their caregivers questionnaires adapted questionnaires in French version of the research team CANHELP.
- Impact and potential consequences of the project: The proposed pilot study should document the satisfaction What patients in palliative situation of their cancer during their care at home, as well as those around them, at the regional level. The implementation of this project will also be used to validate the feasibility of involving these actors in the difficult context of the end of life, to understand their needs, difficulties and feelings regarding the effective care . Thereafter, it may be considered a larger study to complete these first results, before proposing ways to improve whose impact on satisfaction with care remain to be evaluated.
- Conditions
- Cancer, Palliative Care, Home
- Being tested
- Medical telephone contact
- Keywords
- Cancer, Palliative care, home
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical telephone contactOther
Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Medical telephonecontact | Experimental | Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months. Receives: Other: Medical telephone contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient care satisfaction
Evaluation of satisfaction with the care of patients in palliative phase of cancer 15 days after their home return after hospitalization in palliative care.
Measured: 15 days after their home return
Secondary outcomes (1)
Satisfaction of the primary caregiver
Evaluation of the satisfaction of the primary caregiver of maintaining the home of his relatives with cancer in palliative phase
Measured: Satisfaction of the primary caregiver will be evaluated at day 15, months 1 to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Loss of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine GRACH, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207543
- Sponsor's protocol ID
- PALSATIS
- Status last verified
- Mar 2016
- First submitted
- 1 Aug 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Satisfaction in Palliative Cancer When They Return Home After Hospitalization in Palliative Care
- ClinicalTrials.gov ID
- NCT02207543
- Acronym / sponsor ID
- PALSATIS
- Conditions
- Cancer, Palliative Care, Home
- Keywords
- Cancer, Palliative care, home
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 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 proposed work is part of a multidisciplinary approach to continuity of care in the particular context of the palliative phase of cancer. In conducting this study, we would like to characterize, at the regional level, satisfaction with the care of patients and their families in their care home situations palliative cancer. This evaluation will be based on questionnaires adapted versions in French language satisfaction questionnaires recently validated for patients in palliative situation and supported home care.
It will also identify the challenges faced by both patients, caregivers attending physicians.
The evaluation of these elements is a prerequisite to propose ways of improving at a hospital palliative care for output relay and anticipate the coordination of care for optimal care of the patient at home, to meet the expectations of different stakeholders, or even prevent certain readmissions "avoidable".
Detailed description
- Background and rationale of the research project Palliative care is defined, according to the French Society for Support and Palliative Care as acute care delivered in a comprehensive approach to the person with a serious illness, progressive or terminal. Their goal is to relieve physical pain and other symptoms, but also take into account the psychological, social and spiritual suffering. According to this definition, palliative care is interdisciplinary, cater to the patient as a person and his family, at home or in an institution and strive to preserve the best possible quality of life until death.
Very few studies on the quality of life for patients at end of life were conducted in France. Among them, the TRAPADO study is a prospective study to evaluate the quality of care, quality of life and impact on the environment in three parallel cohorts of cancer patients in palliative phase according to their choice of inpatient traditional in palliative care or home. The interim analysis of this study, was published in 2006 in the journal Bulletin of cancer: patients expressed a priority choice for the home; there was a marked alteration of the overall quality of life, as measured by the EORTC-QLQC30, no statistically significant difference between home and hospital; anxiety level was higher in the hospital. Relatives were satisfied with the care of the patient with a good perception of the family fabric and expressed a lower level of psychosocial distress at home. Nevertheless, the terminal readmissions were common with a large majority of hospital deaths.
More recently, Régis Aubry, in the framework of the National Observatory on End of Life (ONFV), has conducted an extensive field survey, published in March 2013, up to the caregivers who meet together near home but also health professionals involved in supporting patients at end of life. The report of this work highlights the importance of developing palliative care in the home including the intervention of specialized teams and coordination of teams working at home.
Indeed, in France, while 81% of the French would "spend their last moments at home" (FIFG, 2010), only 25.5% of deaths occur at home (ONFV, 2012).
Faced with this reality, we were asked to know what elements can explain this discrepancy between this reality and the desire of patients. This issue was the subject of a preliminary study, conducted in 2013 in Lower Normandy region. We chose to study the management of patients with cancer in palliative home situation by their GP after hospitalization Identified beds Palliative Care (LISP) Centre François Baclesse Caen: 19 of the 23 patients assessed, have expressed their willingness on the place of death to their GP, wanted to die at home. Nearly half (48%) of patients in our study died in the hospital. GPs interviewed reported that maintaining the homes of these patients had been facilitated by the relief of distressing symptoms and the establishment of aid.
This finding demonstrates that the GP can often not only coordinate the sometimes complex palliative situations, at home and that the intervention of specialized teams, interdisciplinary, is fundamental to maintaining a home in the best possible conditions.
But what about the patient felt about his quality of life at home? After collecting feedback from GPs Lower Normandy, we would like to continue this work. In this context, we propose a pilot study, single-center, to assess the satisfaction of patients and their families in home support palliative phase of cancer.
- Emerging nature of research topics covered: The proposed work is part of a multidisciplinary approach to continuity of care in the particular context of the palliative phase of cancer. In conducting this study, we would like to characterize, at the regional level, satisfaction with the care of patients and their families in their care home situations palliative cancer. This evaluation will be based on questionnaires adapted versions in French language satisfaction questionnaires recently validated for patients in palliative situation and supported home care.
It will also identify the challenges faced by both patients, caregivers attending physicians.
The evaluation of these elements is a prerequisite to propose ways of improving at a hospital palliative care for output relay and anticipate the coordination of care for optimal care of the patient at home, to meet the expectations of different stakeholders, or even prevent certain readmissions "avoidable".
- Degree of risk-taking and innovative scientific approach: The situation at the end of life patient palliative situation of cancer remains a research context underdeveloped. This study is based on the involvement of patients and their caregivers, at this stage of the disease to assess their satisfaction with care when returning home after a hospital palliative care. It proposes indeed used for this self-administered to patients and their caregivers questionnaires adapted questionnaires in French version of the research team CANHELP.
- Impact and potential consequences of the project: The proposed pilot study should document the satisfaction What patients in palliative situation of their cancer during their care at home, as well as those around them, at the regional level. The implementation of this project will also be used to validate the feasibility of involving these actors in the difficult context of the end of life, to understand their needs, difficulties and feelings regarding the effective care . Thereafter, it may be considered a larger study to complete these first results, before proposing ways to improve whose impact on satisfaction with care remain to be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical telephonecontact | Experimental | Other: Medical telephone contactEvaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient (s) age (s) of 18 or more;
- Patient (s) reached (s) from cancer wholly palliative phase (estimated life expectancy of less than 3 months) in the judgment of the investigator;
- Patient (s) hospital (s) in palliative care and candidate for a return home;
- Patient (s) able to communicate with the investigator or his representative;
- Patient (s) have received clear information on the diagnosis and prognosis of their disease;
Key exclusion criteria (3 listed)
- Patient (s) under guardianship or unable to give informed consent;
- Patient (s) whose cognitive functions can not be questioned.
- Patient (s) whose psychological distress does not participate in the study
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 |
|---|---|---|
| Medical telephone contactEvaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months. | Other | Medical telephonecontact |
Primary outcome
Patient care satisfaction
Time frame: 15 days after their home return
Evaluation of satisfaction with the care of patients in palliative phase of cancer 15 days after their home return after hospitalization in palliative care.
1 secondary outcome
Satisfaction of the primary caregiver
Time frame: Satisfaction of the primary caregiver will be evaluated at day 15, months 1 to 6
Results and safety
The study was stopped early (reason given: Loss of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical telephone contact in people with Cancer and Palliative Care, run by Centre Francois Baclesse at 1 site 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 3 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: stopped early, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Loss of patients). Results are not available in the source record.
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?
Patient care satisfaction (time frame: 15 days after their home return). 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 10 Feb 2017.