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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

Conditions
-----------------
Supportive Care Needs

Intervention / Treatment
-----------------
* Other: Evaluation of the supportive care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: observation cohort<br>Questionnaire to assess the supportive care needs | Other: Evaluation of the supportive care<br>* Evaluation of interest of a systematic screening for oncological supportive care needs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)). | 4 to 6 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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. | 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 | 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. | 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 | 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) | 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire) |