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

NCT03951701 | Completed

• 2 other identifiers: 2018-022018-A01425-50
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Supportive Care Needs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Evaluation of initial supportive care needs by the self-assessment questionnaire

  baseline

• Assess the correlation between supportive care needs and age

  This analyse will be realized at the end of the study (9 weeks after baseline)

• Assess the correlation between supportive care needs and sexe

  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

  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

  This analyse will be realized at the end of the study (9 weeks after baseline)

Study Arms (1)

observation cohort

EXPERIMENTAL

Questionnaire to assess the supportive care needs

Other: Evaluation of the supportive care

Interventions

Evaluation of the supportive care OTHER

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

observation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minor or protected adult
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (1)

Centre Paul Strauss

Strasbourg, 67065, France

Location

Study Officials

• Véronique FRASIE, Md

  Centre Paul Strauss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: September 17, 2018
• Primary Completion: December 5, 2018
• Study Completion: January 18, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

FR (1)