Supportive Care NeedsDBSOSNCT03951701
Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs
A study testing Evaluation of the supportive care in people with Supportive Care Needs, run by Centre Paul Strauss at 1 site in France.
Trial summary
Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Supportive Care Needs
- What is being tested?
- Evaluation of the supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2018to 18 Jan 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient treated for a cancer
- Age ≥ 18 years old
- Receiving treatment (chemotherapy and/or radiotherapy) in day hospital and/or supportive care department
- Able to speak, read and understand French
- Able to communicate by phone
- Written informed consent obtained from the patient
- Registration in a national health care system
Who cannot join
- Minor or protected adult
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Interest of a Systematic Screening for Oncological Supportive Care
Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.
Read the detailed description
The study will unfold in the followed day hospital's departments of the Paul Strauss Cancer Center (Strasbourg, France) : supportive care department, chemiotherapy department and radiotherapy department. The study is based on two questionnaires that include six sections : nutrition, social, psychologic, physiotherapy, pain and supportive care needs evaluation.
The first questionnaire gives information about the patient and allow to screen supportive care needs. It should be read by medical or paramedical staff who report the function of the reader and options that are proposed to the patient after reading the questionnaire.
The second questionnaire will be done after 4 to 6 weeks by a phone call from the clinical research nurse. The objective of this questionnaire is to determine what kind of care have been provided.
- Conditions
- Supportive Care Needs
- Being tested
- Evaluation of the supportive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the supportive careOther
Evaluation of interest of a systematic screening for oncological supportive care needs
| Study group | Role | What they receive |
|---|---|---|
| observation cohort | Experimental | Questionnaire to assess the supportive care needs Receives: Other: Evaluation of the supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call
Assess the percentage of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional. The use of supportive cares is evaluated with an hetero-questionnaire created for this study. The hetero-questionnaire consists in a phone call to evaluate the evolution of each item of the self-assessment questionnaire (which includes 6 evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items)).
Measured: 4 to 6 weeks after baseline
Secondary outcomes (7)
Evaluation of initial supportive care needs by the self-assessment questionnaire
Assess the percentage of initial supportive care needs evaluated by the self-assessment questionnaire created for this study. It includes evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items).
Measured: baseline
Assess the correlation between supportive care needs and age
Correlate the percentage of supportive care needs to age by a Pearson Chi squared test
Measured: This analyse will be realized at the end of the study (9 weeks after baseline)
Assess the correlation between supportive care needs and sexe
Correlate the percentage of supportive care needs to sexe by a Pearson Chi squared test.
Measured: This analyse will be realized at the end of the study (9 weeks after baseline)
Assess the correlation between supportive care needs and type of cancer
Correlate the percentage of supportive care needs to the type of cancer by a Pearson Chi squared test
Measured: This analyse will be realized at the end of the study (9 weeks after baseline)
Compare the percentage of using a supportive care professional judgement in regard to read and unread questionnaires by medical staff
Assess the percentage of using a supportive care when the medical staff read the completed questionnaire. Assess the percentage of using a supportive care when the medical staff didn't read the completed questionnaire. Then compare these values by using a T- test of Student.
Measured: This analyse will be realized at the end of the study (9 weeks after baseline)
Compare the percentage of using a supportive care professional judgement in regard to the function of the medical staff member
Assess the percentage of using a supportive care when the medical staff who read the completed questionnaire is a doctor, a nurse, or an auxiliary nurse . Then compare these values by using a T- test of Student
Measured: This analyse will be realized at the end of the study (9 weeks after baseline)
Assess the percentage of requirement to the physician during the study
Assess the percentage of requirement to the physician during the study by asking each patient (by phone call)
Measured: 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start17 Sep 2018
- Primary completion5 Dec 2018
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supportive Care NeedsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique FRASIE, Md, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951701
- Sponsor's protocol ID
- 2018-02
- Other IDs
- 2018-A01425-50
- Acronym
- DBSOS
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interest of a Systematic Screening for Oncological Supportive Care
- ClinicalTrials.gov ID
- NCT03951701
- Acronym / sponsor ID
- DBSOS / 2018-02
- Conditions
- Supportive Care Needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 15 May 2019 (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.
Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.
Detailed description
The study will unfold in the followed day hospital's departments of the Paul Strauss Cancer Center (Strasbourg, France) : supportive care department, chemiotherapy department and radiotherapy department. The study is based on two questionnaires that include six sections : nutrition, social, psychologic, physiotherapy, pain and supportive care needs evaluation.
The first questionnaire gives information about the patient and allow to screen supportive care needs. It should be read by medical or paramedical staff who report the function of the reader and options that are proposed to the patient after reading the questionnaire.
The second questionnaire will be done after 4 to 6 weeks by a phone call from the clinical research nurse. The objective of this questionnaire is to determine what kind of care have been provided.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation cohort | Experimental | Other: Evaluation of the supportive careQuestionnaire to assess the supportive care needs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient treated for a cancer
- Age ≥ 18 years old
- Receiving treatment (chemotherapy and/or radiotherapy) in day hospital and/or supportive care department
- Able to speak, read and understand French
- Able to communicate by phone
Key exclusion criteria (2 listed)
- Minor or protected adult
- Pregnant or breastfeeding woman
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 supportive careEvaluation of interest of a systematic screening for oncological supportive care needs | Other | observation cohort |
Primary outcome
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call
Time frame: 4 to 6 weeks after baseline
Assess the percentage of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional. The use of supportive cares is evaluated with an hetero-questionnaire created for this study. The hetero-questionnaire consists in a phone call to evaluate the evolution of each item of the self-assessment questionnaire (which includes 6 evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items)).
7 secondary outcomes
Evaluation of initial supportive care needs by the self-assessment questionnaire
Time frame: baseline
Assess the correlation between supportive care needs and age
Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)
Assess the correlation between supportive care needs and sexe
Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)
Assess the correlation between supportive care needs and type of cancer
Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)
Compare the percentage of using a supportive care professional judgement in regard to read and unread questionnaires by medical staff
Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)
Compare the percentage of using a supportive care professional judgement in regard to the function of the medical staff member
Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)
Assess the percentage of requirement to the physician during the study
Time frame: 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)
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 23 May 2019.
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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.
Véronique FRASIE, Md principal investigator
Centre Paul Strauss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the supportive care in people with Supportive Care Needs, run by Centre Paul Strauss 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 7 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 23 May 2019. 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?
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call (time frame: 4 to 6 weeks after baseline). 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 23 May 2019.