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Group-based or Individual Information About Disease and Treatment Plan

25. januar 2017 oppdatert av: Norwegian University of Science and Technology

Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan

The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.

Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.

The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.

Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.

Studietype

Intervensjonell

Registrering (Faktiske)

98

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Norge
      • Trondheim, Norge
        • St Olavs Hospital

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

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  • Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
  • Prostate cancer patients that are candidates for curative radiotherapy
  • Signed informed consent
  • Patient expected to be able to complete the planned treatment and the study procedures
  • 18years or older

Exclusion Criteria:

-Patients not fulfilling inclusion criteria

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group and Individual information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Annen: Group information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Ingen inngripen: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knowledge
Tidsramme: 1 week
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
1 week
Knowledge
Tidsramme: 2 weeks
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
2 weeks
Knowledge
Tidsramme: 9 weeks
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
9 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Life
Tidsramme: 9 weeks
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
9 weeks
Patients Subjective state of information
Tidsramme: 1 week
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
1 week
Patients Subjective state of information
Tidsramme: 2 weeks
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
2 weeks
Patients Subjective state of information
Tidsramme: 9 weeks
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
9 weeks
Anxiety
Tidsramme: 1 week
STAI-State and Trait Anxiety Inventory
1 week
Anxiety
Tidsramme: 2 weeks
STAI-State and Trait Anxiety Inventory
2 weeks
Anxiety
Tidsramme: 9 weeks
STAI-State and Trait Anxiety Inventory
9 weeks
Adverse events
Tidsramme: 2 weeks
CTCEA, Common Terminology Criteria for Adverse Events
2 weeks
Adverse events
Tidsramme: 9 weeks
CTCEA, Common Terminology Criteria for Adverse Events
9 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Norwegian University of Science and Technology

Samarbeidspartnere

St. Olavs Hospital

Etterforskere

  • Hovedetterforsker: Stein Kaasa, MD, Prof., St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
  • Studieleder: Ola Berger, MD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
  • Studiestol: Bjørn H Gønberg, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
  • Studiestol: Kari Sand, Cand Philol, PRC, European Palliative Care Research Center
  • Studiestol: Jo Å Lund, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
  • Studiestol: Jon H Loge, MD, Prof., National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. oktober 2012

Primær fullføring (Faktiske)

1. juli 2015

Studiet fullført (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først innsendt

21. september 2012

Først innsendt som oppfylte QC-kriteriene

1. oktober 2012

Først lagt ut (Anslag)

4. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • REK2012/1238

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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Forhold

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