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Group-based or Individual Information About Disease and Treatment Plan

25. januar 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Trondheim, Norge
        • St Olavs hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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 indgriben: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian University of Science and Technology

Samarbejdspartnere

St. Olavs Hospital

Efterforskere

  • Ledende efterforsker: 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

21. september 2012

Først indsendt, der opfyldte QC-kriterier

1. oktober 2012

Først opslået (Skøn)

4. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REK2012/1238

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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