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

Supportive Care Needs Clinical Trial

— DBSOS  

Official title:

Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951701
• Other study ID #: 2018-02
• Secondary ID: 2018-A01425-50
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: May 2019
• Source: Centre Paul Strauss
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 18, 2019
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Supportive Care Needs

Intervention

Other:
• Evaluation of the supportive care
Evaluation of interest of a systematic screening for oncological supportive care needs

Locations

Country	Name	City	State
France	Centre Paul Strauss	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Paul Strauss

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)