Clinical trial NCT03951701: Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs
Official title: Evaluation of Interest of a Systematic Screening for Oncological Supportive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supportive Care Needs
Lead sponsor: Centre Paul Strauss
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call
timeFrame: 4 to 6 weeks after baseline
Secondary outcomes:
measure: Evaluation of initial supportive care needs by the self-assessment questionnaire
timeFrame: baseline
measure: Assess the correlation between supportive care needs and age
timeFrame: This analyse will be realized at the end of the study (9 weeks after baseline)
measure: Assess the correlation between supportive care needs and sexe
timeFrame: This analyse will be realized at the end of the study (9 weeks after baseline)
measure: Assess the correlation between supportive care needs and type of cancer
timeFrame: This analyse will be realized at the end of the study (9 weeks after baseline)
measure: Compare the percentage of using a supportive care professional judgement in regard to read and unread questionnaires by medical staff
timeFrame: This analyse will be realized at the end of the study (9 weeks after baseline)
measure: Compare the percentage of using a supportive care professional judgement in regard to the function of the medical staff member
timeFrame: This analyse will be realized at the end of the study (9 weeks after baseline)
measure: Assess the percentage of requirement to the physician during the study
timeFrame: 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
affiliation: Centre Paul Strauss
name: Véronique FRASIE, Md
role: PRINCIPAL_INVESTIGATOR
References: