Liczy się każdy dzień: program stylu życia dla kobiet z rakiem piersi z przerzutami (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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Illinois
-
Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University
-
-
Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College of Wisconsin
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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Adult (≥ 18 years), female
-
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Inny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intervention adherence
Ramy czasowe: 4 months
|
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions |
4 months
|
|
Intervention retention
Ramy czasowe: 4 months
|
Number of women who complete the 4-month data collection |
4 months
|
|
Intervention retention
Ramy czasowe: 8 months
|
Number of women who complete the 8-month data collection |
8 months
|
|
Change in Quality of Life
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Serum Biomarker Inflammation - C-Reactive Protein
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
nRNA and Metabolomics - exploratory
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Melinda Stolley, PhD, Principal Investigator
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 27600
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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