Chaque jour compte : un programme de style de vie pour les femmes atteintes d'un cancer du sein métastatique (EDC)
This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Aims/Objectives
Aim 1. To examine the efficacy of the Every Day Counts intervention in producing significant post-intervention changes in multidimensional QOL in women with MBC.
Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater improvements in multidimensional QOL compared to women randomized to the attention control (n=88).
Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.
Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.
Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention.
Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p) that regulate inflammation and/or Metabolomics will be related to QOL improvements and can identify women more likely to respond to lifestyle changes.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Illinois
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Maywood, Illinois, États-Unis, 60153
- Loyola University
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin
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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:
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Adult (≥ 18 years), female
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Confirmed Metastatic Breast Cancer
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Patients clinically stable with treated brain metastases are eligible
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Written documentation from their oncologist permitting study participation
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Determined to be "clinically stable" by their medical oncologist (i.e., no unintentional weight loss, no new symptoms or change in performance status for the past 4 weeks, no clinical [including laboratory] or radiologic evidence of disease progression, no recent or planned change in anti-neoplastic therapies, no reports of severe pain [≥ Grade 3 per the NCI CTCAE)
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Life expectancy >6 months
-Written documentation from their oncologist permitting study participation
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Access to a mobile phone
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Understand/speak English fluently.
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Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.
Exclusion Criteria:
- Does not meet the above criteria.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Immediate Intervention
The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes: 1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating. |
The lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes. |
|
Autre: Attention Control
The attention control participants will receive a home/work organization intervention:
Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program. |
The attention control participants will receive a home/work organization intervention: Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention adherence
Délai: 4 months
|
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions |
4 months
|
|
Intervention retention
Délai: 4 months
|
Number of women who complete the 4-month data collection |
4 months
|
|
Intervention retention
Délai: 8 months
|
Number of women who complete the 8-month data collection |
8 months
|
|
Change in Quality of Life
Délai: Change from baseline to 4 months
|
Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better. |
Change from baseline to 4 months
|
|
Change in Quality of Life
Délai: change from baseline to 8 months
|
Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better. |
change from baseline to 8 months
|
|
Body composition
Délai: change from baseline to 4 months
|
Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable. |
change from baseline to 4 months
|
|
Body composition
Délai: change from baseline to 8 months
|
Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable. |
change from baseline to 8 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum Biomarker Inflammation - C-Reactive Protein
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Insulin Resistance - Insulin
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Insulin Resistance- Glucose
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Insulin Resistance- C-Peptide
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Adipokine Dysregulation - Adiponectin
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Adipokine Dysregulation - Leptin
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
|
Serum Biomarker Inflammation - Interleukin 6
Délai: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
nRNA and Metabolomics - exploratory
Délai: Baseline to 3 months
|
MTo explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention. analyzed using a Seahorse Bioscience extracellular flux analyzer. |
Baseline to 3 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Melinda Stolley, PhD, Principal Investigator
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 27600
Informations sur les médicaments et les dispositifs, documents d'étude
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