Group-based or Individual Information About Disease and Treatment Plan
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
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Trondheim, Noorwegen
- St Olavs Hospital
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
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Geen tussenkomst: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Knowledge
Tijdsspanne: 1 week
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Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
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1 week
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Knowledge
Tijdsspanne: 2 weeks
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Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
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2 weeks
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Knowledge
Tijdsspanne: 9 weeks
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Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
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9 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of Life
Tijdsspanne: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
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9 weeks
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Patients Subjective state of information
Tijdsspanne: 1 week
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European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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1 week
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Patients Subjective state of information
Tijdsspanne: 2 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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2 weeks
|
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Patients Subjective state of information
Tijdsspanne: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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9 weeks
|
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Anxiety
Tijdsspanne: 1 week
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STAI-State and Trait Anxiety Inventory
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1 week
|
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Anxiety
Tijdsspanne: 2 weeks
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STAI-State and Trait Anxiety Inventory
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2 weeks
|
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Anxiety
Tijdsspanne: 9 weeks
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STAI-State and Trait Anxiety Inventory
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9 weeks
|
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Adverse events
Tijdsspanne: 2 weeks
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CTCEA, Common Terminology Criteria for Adverse Events
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2 weeks
|
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Adverse events
Tijdsspanne: 9 weeks
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CTCEA, Common Terminology Criteria for Adverse Events
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9 weeks
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Stein Kaasa, MD, Prof., St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Studie directeur: Ola Berger, MD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Studie stoel: Bjørn H Gønberg, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Studie stoel: Kari Sand, Cand Philol, PRC, European Palliative Care Research Center
- Studie stoel: Jo Å Lund, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Studie stoel: 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
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REK2012/1238
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