Jokainen päivä on tärkeä: Lifestyle-ohjelma naisille, joilla on metastasoitunut rintasyöpä (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).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Illinois
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Maywood, Illinois, Yhdysvallat, 60153
- Loyola University
-
-
Wisconsin
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Milwaukee, Wisconsin, Yhdysvallat, 53226
- Medical College of Wisconsin
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
|
Muut: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Intervention adherence
Aikaikkuna: 4 months
|
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions |
4 months
|
|
Intervention retention
Aikaikkuna: 4 months
|
Number of women who complete the 4-month data collection |
4 months
|
|
Intervention retention
Aikaikkuna: 8 months
|
Number of women who complete the 8-month data collection |
8 months
|
|
Change in Quality of Life
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Serum Biomarker Inflammation - C-Reactive Protein
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Change from baseline to 4 month
|
Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
nRNA and Metabolomics - exploratory
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Melinda Stolley, PhD, Principal Investigator
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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