Cancerous WoundsNCT02861833
Identifying Coping Strategies of Patients With Cancerous Wound After a Specific Nursing Accompaniment
An observational study of Cancerous Wounds, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This is a first care research focuses on the study of adaptation strategies implemented by cancerous wound patients. Today, advances in treatment generally increases the life expectancy of a patient with cancer. the patients thus live longer with their wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancerous Wounds
- What is being tested?
- nursing support
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Dec 2017
- 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: major patients followed in a cancer ward and holders of a cancerous wound.
Who may be able to join
- Adult patient
- Patient having at least a cancerous wound.
- Patient having read the information leaflet and has given its consent.
- Patient able to meet a French language questionnaire.
Who cannot join
- History or active psychiatric illness.
- Unable to give informed consent.
- Inability to comply with the protocol procedures for geographical, social or psychological.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille Hôpital de Timone
Marseille, 13354
Sébastien SALAS, 04 91 38 45 50, sebastien.salas@ap-hm.fr
Nelly ESPANET, 04 91 38 45 50, Nelly.Espanet@mail.ap-hm.fr
About this study
This is a first care research focuses on the study of adaptation strategies implemented by cancerous wound patients. Today, advances in treatment generally increases the life expectancy of a patient with cancer. the patients thus live longer with their wound. How to live then? The literature review shows that there is research on adaptation strategies in cancer pathology and that different factors seem to interact with these strategies. However the investigators have not found written on the theme cancerous wound and adaptation strategies.
the investigators conducted a pilot study of this research in medical oncology, Prof. service Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers contacted but also areas for improvement. Indeed, the investigators now were doing a study of adaptation strategies implemented by the patient time T of his life. However, adaptation is a process in constant motion, the investigators want to identify two different time patients coping strategies following a specific charge nurse taking.
- Conditions
- Cancerous Wounds
- Being tested
- nursing support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing supportOther
Determining the Variability of adaptation strategies and correlations with specific nursing management, individual and contextual characteristics of patients with cancerous wounds
| Study group | Role | What they receive |
|---|---|---|
| Patients with a cancerous wound | major patients followed in a cancer ward and holders of a cancerous wound. Receives: Other: nursing support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of the main demographic, clinical, and psychological
Questionnaires for patients rely on the concept of Coping,It refers to the responses and reactions that an individual develops to control aversive situation.
Measured: one month
Secondary outcomes (2)
main clinical features
The questionnaires are based on the concept of the coping, the nursing model on adaptation strategies developed by Callista Roy.
Measured: one month
main psychological characteristics
The questionnaires are based on the concept of the coping, the nursing model on adaptation strategies developed by Callista Roy.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startMay 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancerous WoundsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861833
- Sponsor's protocol ID
- RC12_3976 - 2215
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Coping Strategies of Patients With Cancerous Wound After a Specific Nursing Accompaniment
- ClinicalTrials.gov ID
- NCT02861833
- Acronym / sponsor ID
- RC12_3976 - 2215
- Conditions
- Cancerous Wounds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Aug 2016 (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.
This is a first care research focuses on the study of adaptation strategies implemented by cancerous wound patients. Today, advances in treatment generally increases the life expectancy of a patient with cancer. the patients thus live longer with their wound. How to live then? The literature review shows that there is research on adaptation strategies in cancer pathology and that different factors seem to interact with these strategies. However the investigators have not found written on the theme cancerous wound and adaptation strategies.
the investigators conducted a pilot study of this research in medical oncology, Prof. service Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers contacted but also areas for improvement. Indeed, the investigators now were doing a study of adaptation strategies implemented by the patient time T of his life. However, adaptation is a process in constant motion, the investigators want to identify two different time patients coping strategies following a specific charge nurse taking.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a cancerous wound | – | Other: nursing supportmajor patients followed in a cancer ward and holders of a cancerous wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major patients followed in a cancer ward and holders of a cancerous wound.
Key inclusion criteria (4 listed)
- Adult patient
- Patient having at least a cancerous wound.
- Patient having read the information leaflet and has given its consent.
- Patient able to meet a French language questionnaire.
Key exclusion criteria (3 listed)
- History or active psychiatric illness.
- Unable to give informed consent.
- Inability to comply with the protocol procedures for geographical, social or psychological.
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 |
|---|---|---|
| nursing supportDetermining the Variability of adaptation strategies and correlations with specific nursing management, individual and contextual characteristics of patients with cancerous wounds | Other | Patients with a cancerous wound |
Primary outcome
Descriptive analysis of the main demographic, clinical, and psychological
Time frame: one month
Questionnaires for patients rely on the concept of Coping,It refers to the responses and reactions that an individual develops to control aversive situation.
2 secondary outcomes
main clinical features
Time frame: one month
main psychological characteristics
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancerous Wounds, run by Assistance Publique Hopitaux De Marseille 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 4 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: status not confirmed, as of the sponsor's last update on 10 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien SALAS (04 91 38 45 50, sebastien.salas@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of the main demographic, clinical, and psychological (time frame: one month). 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 Aug 2016.