A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
7 mai 2019 mis à jour par: Case Comprehensive Cancer Center
A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.
Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.
The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.
Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.
Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.
Type d'étude
Interventionnel
Inscription (Réel)
17
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ohio
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Cleveland, Ohio, États-Unis, 44106
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
Women at high risk of breast cancer due to one or more of the following:
- Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
- Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
- Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
- Ability to access the internet and watch videos online.
- Valid email address.
- Self-reported sleep duration of 6 hours per night or less
Exclusion Criteria:
- Previous diagnosis of cancer.
- Lack of ability to read and converse in English.
- Lack of ability to give informed consent.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: GO! To Sleep
Participants in the intervention group will be provided with a code and website address to participate in this program.
This program includes reminder emails and is 6 weeks in duration.
Participants will be given a blood draw to measure biomarkers.
|
Controlled sleep intervention.
Provide online education and reminder emails on improving sleep behavior
blood sample measured for stress and sleep markers
Autres noms:
Assessment of sleep quality.
This is a continuous measure from 0 (best) to 21 (worst).
Sleep duration will be obtained directly from responses.
|
|
Comparateur actif: informational control
Participants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers.
|
blood sample measured for stress and sleep markers
Autres noms:
Assessment of sleep quality.
This is a continuous measure from 0 (best) to 21 (worst).
Sleep duration will be obtained directly from responses.
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Délai: Change from baseline to post intervention, around 8 weeks after baseline
|
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
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Change from baseline to post intervention, around 8 weeks after baseline
|
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Difference in change in Insomnia Severity Index (ISI) score between groups
Délai: Change from baseline to post intervention, around 8 weeks after baseline
|
Sleep quality will be measured with the insomnia severity index (ISI).
A validated instrument for sleep quality
|
Change from baseline to post intervention, around 8 weeks after baseline
|
|
Difference in change in sleep duration between groups
Délai: Change from baseline to post intervention, around 8 weeks after baseline
|
Sleep duration will be obtained by self-report from responses to the PSQI
|
Change from baseline to post intervention, around 8 weeks after baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in change of SF-12 score from baseline to post-intervention between groups
Délai: Change from baseline to 6 months post intervention
|
The effectiveness of changing health-related quality of life after the GO!
To Sleep program will he measured with the self-reported survey SF-12
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Change from baseline to 6 months post intervention
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Correlation of joint changes in biomarker levels with PSQI and ISI
Délai: Change from baseline to 6 months post intervention
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This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
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Change from baseline to 6 months post intervention
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Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Délai: Change from baseline to 6 months post intervention
|
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
|
Change from baseline to 6 months post intervention
|
|
Difference in change in Insomnia Severity Index (ISI) score between groups
Délai: Change from baseline to 6 months post intervention
|
Sleep quality will be measured with the insomnia severity index (ISI).
A validated instrument for sleep quality
|
Change from baseline to 6 months post intervention
|
|
Difference in change in sleep duration between groups
Délai: Change from baseline to 6 months post intervention
|
Sleep duration will be obtained by self-report from responses to the PSQI
|
Change from baseline to 6 months post intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 août 2015
Achèvement primaire (Réel)
23 mars 2017
Achèvement de l'étude (Réel)
23 juillet 2017
Dates d'inscription aux études
Première soumission
23 novembre 2015
Première soumission répondant aux critères de contrôle qualité
23 novembre 2015
Première publication (Estimation)
25 novembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2019
Dernière vérification
1 mai 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CASE6114
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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