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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Trondheim, Norvège
- St Olavs Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
|
|
Aucune intervention: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knowledge
Délai: 1 week
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
1 week
|
|
Knowledge
Délai: 2 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
2 weeks
|
|
Knowledge
Délai: 9 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
9 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of Life
Délai: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
|
9 weeks
|
|
Patients Subjective state of information
Délai: 1 week
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
1 week
|
|
Patients Subjective state of information
Délai: 2 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
2 weeks
|
|
Patients Subjective state of information
Délai: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
9 weeks
|
|
Anxiety
Délai: 1 week
|
STAI-State and Trait Anxiety Inventory
|
1 week
|
|
Anxiety
Délai: 2 weeks
|
STAI-State and Trait Anxiety Inventory
|
2 weeks
|
|
Anxiety
Délai: 9 weeks
|
STAI-State and Trait Anxiety Inventory
|
9 weeks
|
|
Adverse events
Délai: 2 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
2 weeks
|
|
Adverse events
Délai: 9 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
9 weeks
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Stein Kaasa, MD, Prof., St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Directeur d'études: Ola Berger, MD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Chaise d'étude: Bjørn H Gønberg, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Chaise d'étude: Kari Sand, Cand Philol, PRC, European Palliative Care Research Center
- Chaise d'étude: Jo Å Lund, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Chaise d'étude: 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
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REK2012/1238
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