Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

21 maj 2019 uppdaterad av: Centre Paul Strauss

Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

134

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Strasbourg, Frankrike, 67065
        • Centre Paul Strauss

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: observation cohort
Questionnaire to assess the supportive care needs
Övrig: Evaluation of the supportive care
Evaluation of interest of a systematic screening for oncological supportive care needs

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call
Tidsram: 4 to 6 weeks after baseline
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evaluation of initial supportive care needs by the self-assessment questionnaire
Tidsram: baseline
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
Tidsram: This analyse will be realized at the end of the study (9 weeks after baseline)
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
Tidsram: This analyse will be realized at the end of the study (9 weeks after baseline)
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
Tidsram: This analyse will be realized at the end of the study (9 weeks after baseline)
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
Tidsram: This analyse will be realized at the end of the study (9 weeks after baseline)
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
Tidsram: This analyse will be realized at the end of the study (9 weeks after baseline)
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
Tidsram: 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)
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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre Paul Strauss

Utredare

  • Huvudutredare: Véronique FRASIE, Md, Centre Paul Strauss

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 september 2018

Primärt slutförande (Faktisk)

5 december 2018

Avslutad studie (Faktisk)

18 januari 2019

Studieregistreringsdatum

Först inskickad

14 maj 2019

Först inskickad som uppfyllde QC-kriterierna

14 maj 2019

Första postat (Faktisk)

15 maj 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 maj 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 maj 2019

Senast verifierad

1 maj 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2018-02
  • 2018-A01425-50 (Annan identifierare: ANSM)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Stödjande vårdbehov

Kliniska prövningar på Evaluation of the supportive care

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Italy

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera