Ogni giorno conta: un programma sullo stile di vita per le donne con carcinoma mammario metastatico (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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Illinois
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Maywood, Illinois, Stati Uniti, 60153
- Loyola University
-
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College of Wisconsin
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Altro: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intervention adherence
Lasso di tempo: 4 months
|
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions |
4 months
|
|
Intervention retention
Lasso di tempo: 4 months
|
Number of women who complete the 4-month data collection |
4 months
|
|
Intervention retention
Lasso di tempo: 8 months
|
Number of women who complete the 8-month data collection |
8 months
|
|
Change in Quality of Life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Serum Biomarker Inflammation - C-Reactive Protein
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
nRNA and Metabolomics - exploratory
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Melinda Stolley, PhD, Principal Investigator
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 27600
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