- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01329068
Patient Empowerment by Group Medical Consultations (GMC)
Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in the course of their lives . They face a difficult choice: either a preventive removal of the breast(s) or an intensive inspection process.
After primary treatment of breast cancer, patients will be followed for 5-10 years to diagnose recurrence or a new primary tumor in an early stage; to support the patient during hormonal treatment; to educate the patient about risk factors and healthy life style; and to provide psychosocial support.
Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is offered in regular, one-to-one medical visits. Experience shows that in an individual visit it is often not possible to give all aspects that are important, enough attention. The group medical consultation (GMC) is a new form of medical visits where the physician or nurse practitioner performs a series of one-to-one consultations in the presence of 8 to10 other patients. A social worker accompanies this process. Patients in group consultations may gather more information because they learn from each other and there is relatively more time compared to a regular consultation. Research shows that both patients and caregivers are more satisfied with care after a group consultation compared to individual visits. After a GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months. Using this iPad, patients can contact the women they have met during the GMC as well as health care professionals by several communication channels, including virtual group meetings. This approach provides a unique combination of both social support and professional education concerning survivorship in an e-health environment.However, it is also known that group sessions may be counterproductive for some patients, for example because they are frightened by the stories of others. The goal of this study is to examine whether group visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and for patients in follow-up after breast cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Gelderland
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Nijmegen, Gelderland, Pays-Bas, 6500 HB
- Recrutement
- Radboud University Nijmegen Medical Centre
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Chercheur principal:
- H.W.M. van Laarhoven, Md
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Participants: patients in follow-up after breast cancer
- Women ≥ 18 years of age with histologically proven breast cancer.
- Primary treatment (surgery, radiotherapy, chemotherapy) completed maximally 5 years ago.
Participants: women with a BRCA mutation
- Women ≥ 25 years of age with a proven BRCA1 or BRCA2 mutation.
- Carrier of a BRCA1 or BRCA2 mutation, diagnosed maximally two years before inclusion.
Exclusion Criteria:
Participants: patients in follow-up after breast cancer
- Metastatic breast cancer
- Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
- A history of prophylactic mastectomy.
- Current psychiatric disease precluding consultations in a group.
- Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire
Participants: women with a BRCA mutation
- Metastatic breast cancer
- Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
- A history of prophylactic mastectomy.
- Current psychiatric disease precluding consultations in a group.
- Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Individual consult
regular individual consult
|
regular individual consultations
|
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Comparateur actif: group medical consult
regular group medical consult
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group medical consult
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
Délai: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
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BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Questionnaires for patients and health care professionals, observations and user measurements of the iPads.
Délai: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
|
IPads:
|
BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: H.W.M. van Laarhoven, Md PhD, Radboud University Medical Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UMCNONCO201006
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