Formation des pairs navigateurs pour améliorer les soins de survie chez les survivantes afro-américaines du cancer du sein
Sister Survivor : Améliorer les soins de survie des femmes afro-américaines atteintes d'un cancer du sein
This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
I. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 6 months.
II. To promote adherence to the SCP schedule of follow-up examinations at 12 months.
SECONDARY OBJECTIVES:
I. To evaluate the effect of PN on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related QOL at 6 months.
OUTLINE: PNs are trained on medical issues and resources, and SCP. Participants are then randomized to 1 of 2 treatment arms.
ARM I: Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and American Cancer Society (ACS) materials.
ARM II: Participants receive ACS materials.
After completion of study treatment, patients are followed up at 6 and 12 months.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Duarte, California, États-Unis, 91010
- City of Hope Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- TRIAL SUBJECTS:
- Patient age 18 years or older who self-identifies as African-American
- In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer
- Receiving health care primarily through an health maintenance organization (HMO)
- Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different
- Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded
- PEER NAVIGATORS:
- At least 25 years of age who self-identifies as African-American
- Previously participated in any type of research study
- Has at least high school education
- Has been diagnosed with breast cancer, currently in remission or eradicated
- Belongs to a breast cancer support group
- Has a valid driver's license
- Owns an operational vehicle
- Has access to a personal computer with internet access
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 |
|---|---|
|
Expérimental: Arm I (PN and ACS material)
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials. |
Ancillary studies
Autres noms:
Ancillary studies Receive ACS material
Autres noms:
Undergo PN session
Autres noms:
Ancillary studies |
|
Comparateur actif: Arm II (ACS material)
Participants receive ACS materials only. |
Ancillary studies
Autres noms:
Ancillary studies Receive ACS material
Autres noms:
Ancillary studies |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ability of peer navigation to improve understanding of SCP
Délai: At 6 months
|
Chi-square and t-tests will be used to compare the baseline characteristics of subjects randomized to PN intervention vs control. For subjects in the intervention arm, the number of navigation sessions received will be reported, and correlated factors will be explored. The number of subjects navigated per PN will also be reported. Nonevaluable and evaluable subjects (defined at 6 and 12 months) will be compared. Site of care will be handled as a cluster level variable in generalized linear mixed (GLM) regression models. |
At 6 months
|
|
Adherence to the SCP schedule of follow-up examinations
Délai: At 12 months
|
Measured using a newly created, 50-point scale that gives equal weight to completion of the recommended: physical exams, imaging, pelvic exam, annual oncology visit, and breast self-exams. |
At 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Qualité de vie physique et liée à la santé
Délai: A 6 mois
|
A 6 mois
|
|
|
Effect of PN on change in medical efficacy
Délai: Baseline to 6 months
|
Exploratory analyses will analyze the effect of PN intervention actually received, using the number of PN sessions completed and the quality of the subject's PN as measured by PN's post-training level of acuity and utility. |
Baseline to 6 months
|
|
Preparedness for life as new survivor (PLANS)
Délai: At 6 months
|
PLANS consists of two subscales that measure patients' knowledge and self efficacy with regards to their Access and Quality of Survivorship Care Plan (SCP) and adherence with regard to following these tasks. The knowledge subscale (Cronbach's alpha 0.90) and adherence subscale (Cronbach's alpha 0.70) have good reliability. |
At 6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kimlin Ashing-Giwa, City of Hope Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- Tumeurs par site
- Tumeurs
- Maladies de la peau
- Maladies du sein
- Maladies de la peau et du tissu conjonctif
- Tumeurs mammaires
- Techniques d'investigation
- Services de santé
- Conseils de soins de santé
- Services de santé infantile
- Services de santé communautaire
- Services de santé préventifs
- Disciplines et activités comportementales
- Services de santé mentale
- Méthodes
- Intervention précoce, éducatif
- Conseil
Autres numéros d'identification d'étude
- 11115
- NCI-2011-03229 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
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