- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01419613
Promoting a Healthier Lifestyle Among Breast Cancer Survivors
Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants will be randomly assigned to one of two groups. One group of breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. The other group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
Participants will have three consultations with a health counselor. The first two consultations will take place in-person and the third consultation will take place via telephone. Participants will also be asked to complete questionnaires assessing their physical and mental well-being, their dietary habits, and their physical activity habits at four time-points: in-person during their first study visit, via mail or through an online survey 6 weeks later, in-person 12 weeks later, and via mail or through an online survey 24 weeks later. Additionally, during their first study visit and 12 weeks later, their level of aerobic fitness will be tested by having participants walk a long hallway for six minutes.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Florida
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Tampa, Florida, États-Unis, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ≥ 18 years of age;
- be capable of speaking and reading English;
- be diagnosed with stage 0-II breast cancer;
- be currently disease free;
- have been treated surgically for breast cancer;
- have completed chemotherapy and/or radiotherapy at least three months but no more than two years prior;
- be physically able to exercise as measured by the Physical Activity Readiness Questionnaire-Revised (Thomas, Reading, & Shephard, 1992) ;
- be currently physically inactive as measured by the Godin Leisure Time Exercise Questionnaire (Godin & Shepard, 1985); and
- be contemplating increasing physical activity as measured by the Exercise Stages of Change - Short Form (Marcus, Selby, Niaura, & Rossi, 1992).
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: Entrevue motivationnelle
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Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
|
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Comparateur actif: Physical Activity Counseling
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The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Who Increased Activity After Motivational Interviewing
Délai: 24 Weeks Per Participant
|
The primary objective of this study is to evaluate the efficacy of a brief Motivational Interviewing (MI) based intervention, relative to a time and attention control intervention (healthy lifestyle counseling), in promoting physical activity among early-stage breast cancer survivors who are physically inactive but are contemplating increasing their level of physical activity.
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24 Weeks Per Participant
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Desired Impact on Symptoms After Motivational Interviewing
Délai: 24 Weeks Per Participant
|
The secondary objectives of this study are (1) to examine the impact of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness; and
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24 Weeks Per Participant
|
|
Number of Participants With Desired Effects From Increased Physical Activity
Délai: 24 Weeks Per Participant
|
(2) to explore whether the degree of change in physical activity acts as a mediator of the expected benefits of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness.
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24 Weeks Per Participant
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul B. Jacobsen, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Publications et liens utiles
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MCC-16265
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