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Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs

Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03951701
Acronym
DBSOS
Enrollment
134
Registered
2019-05-15
Start date
2018-09-17
Completion date
2019-01-18
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supportive Care Needs

Brief summary

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.

Interventions

OTHEREvaluation of the supportive care

Evaluation of interest of a systematic screening for oncological supportive care needs

Sponsors

Centre Paul Strauss
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Minor or protected adult * Pregnant or breastfeeding woman

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call4 to 6 weeks after baselineAssess 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)).

Secondary

MeasureTime frameDescription
Assess the correlation between supportive care needs and ageThis analyse will be realized at the end of the study (9 weeks after baseline)Correlate the percentage of supportive care needs to age by a Pearson Chi squared test
Assess the correlation between supportive care needs and sexeThis analyse will be realized at the end of the study (9 weeks after baseline)Correlate the percentage of supportive care needs to sexe by a Pearson Chi squared test.
Assess the correlation between supportive care needs and type of cancerThis analyse will be realized at the end of the study (9 weeks after baseline)Correlate the percentage of supportive care needs to the type of cancer by a Pearson Chi squared test
Evaluation of initial supportive care needs by the self-assessment questionnairebaselineAssess 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).
Compare the percentage of using a supportive care professional judgement in regard to the function of the medical staff memberThis analyse will be realized at the end of the study (9 weeks after baseline)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
Assess the percentage of requirement to the physician during the study4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)Assess the percentage of requirement to the physician during the study by asking each patient (by phone call)
Compare the percentage of using a supportive care professional judgement in regard to read and unread questionnaires by medical staffThis analyse will be realized at the end of the study (9 weeks after baseline)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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026