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

21. mai 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

134

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: observation cohort
Questionnaire to assess the supportive care needs
Annen: Evaluation of the supportive care
Evaluation of interest of a systematic screening for oncological supportive care needs

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of initial supportive care needs by the self-assessment questionnaire
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Paul Strauss

Etterforskere

  • Hovedetterforsker: Véronique FRASIE, Md, Centre Paul Strauss

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. september 2018

Primær fullføring (Faktiske)

5. desember 2018

Studiet fullført (Faktiske)

18. januar 2019

Datoer for studieregistrering

Først innsendt

14. mai 2019

Først innsendt som oppfylte QC-kriteriene

14. mai 2019

Først lagt ut (Faktiske)

15. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2018-02
  • 2018-A01425-50 (Annen identifikator: ANSM)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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