Acute LeukemiaSPIEVIENCT03698656
Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers.
An observational study of Acute Leukemia and Lymphoma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Lymphoma
- What is being tested?
- Spiritual Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2018to 1 Oct 2020
- 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: Patients with acute leukaemia or lymphoma during the first month after diagnosis or after first relapse hospitalised in Toulouse Cancer University Hospital
Who may be able to join
- Patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse
- More than 17 years old
- French language
- Having signed informed consent
Who cannot join
- Patients requiring palliative care
- Important psychic vulnerability or severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study
Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer
Read the detailed description
Patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period.
The intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). Quality of life (FACT-G) and spiritual well-being (FACIT-SP12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview).
This pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.
- Conditions
- Acute Leukemia, Lymphoma
- Being tested
- Spiritual Interview
- Keywords
- Spiritual dimension, Hematologic cancer, Acute leukemia, Lymphoma, Nurse interview, Quality of life
- Medical subject headings
- Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual InterviewBehavioural
Three patient interviews (45 to 60 minutes) will be conducted by the study nurse at the beginning of the study and approximately 2 and 4 month later, according to the program of the medical care. Each interview will be conducted according the active listening method of Carl Rogers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period
Number of patients having entered the study with regards to the number of the contacted patients, and number of patients having completed the six-eight month study with regards to the patients having entered the study
Measured: 6-8 months
Secondary outcomes (2)
Rate of entire completion of quality of life scales
Rate of entire completion of functional assessment of cancer therapy - general and The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being 12 items scales whose values will be used in order to determine the sample size of a further randomised controlled trial
Measured: 6-8 months
Number of contacted patients with regards to the number of eligible hospitalized patients
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie FLOUCAUD, IDE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698656
- Sponsor's protocol ID
- RC31/17/0332
- Acronym
- SPIEVIE
- Status last verified
- Dec 2020
- First submitted
- 1 Oct 2018
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study
- ClinicalTrials.gov ID
- NCT03698656
- Acronym / sponsor ID
- SPIEVIE / RC31/17/0332
- Conditions
- Acute Leukemia, Lymphoma
- Keywords
- Spiritual dimension, Hematologic cancer, Acute leukemia, Lymphoma, Nurse interview, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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.
Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer
Detailed description
Patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period.
The intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). Quality of life (FACT-G) and spiritual well-being (FACIT-SP12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview).
This pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute leukaemia or lymphoma during the first month after diagnosis or after first relapse hospitalised in Toulouse Cancer University Hospital
Key inclusion criteria (4 listed)
- Patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse
- More than 17 years old
- French language
- Having signed informed consent
Key exclusion criteria (2 listed)
- Patients requiring palliative care
- Important psychic vulnerability or severe psychiatric disorders
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 |
|---|---|---|
| Spiritual InterviewThree patient interviews (45 to 60 minutes) will be conducted by the study nurse at the beginning of the study and approximately 2 and 4 month later, according to the program of the medical care. Each interview will be conducted according the active listening method of Carl Rogers. | Behavioural | – |
Primary outcome
Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period
Time frame: 6-8 months
Number of patients having entered the study with regards to the number of the contacted patients, and number of patients having completed the six-eight month study with regards to the patients having entered the study
2 secondary outcomes
Rate of entire completion of quality of life scales
Time frame: 6-8 months
Number of contacted patients with regards to the number of eligible hospitalized patients
Time frame: 6-8 months
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 28 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Valérie FLOUCAUD, IDE principal investigator
University Hospital, Toulouse
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 Acute Leukemia and Lymphoma, run by University Hospital, Toulouse 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 2 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 28 Dec 2020. 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 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?
Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period (time frame: 6-8 months). 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 28 Dec 2020.