Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs (DBSOS)

Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

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

Study Overview

• Status: Completed
• Conditions: Supportive Care Needs
• Intervention / Treatment: Other: Evaluation of the supportive care

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67065
    • Centre Paul Strauss

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: observation cohort; Questionnaire to assess the supportive care needs	Other: Evaluation of the supportive care; Evaluation of interest of a systematic screening for oncological supportive care needs

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)

Collaborators and Investigators

• Sponsor: Centre Paul Strauss
• Investigators: Principal Investigator: Véronique FRASIE, Md, Centre Paul Strauss

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): December 5, 2018
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-02; 2018-A01425-50 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No