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Hver dag teller: Et livsstilsprogram for kvinner med metastatisk brystkreft (EDC)

2. oktober 2026 oppdatert av: Melinda Stolley, Medical College of Wisconsin

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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Adult (≥ 18 years), female

  • Confirmed Metastatic Breast Cancer

  • Patients clinically stable with treated brain metastases are eligible

  • Written documentation from their oncologist permitting study participation

  • 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)

  • Life expectancy >6 months

    -Written documentation from their oncologist permitting study participation

  • Access to a mobile phone

  • Understand/speak English fluently.

  • Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.

Exclusion Criteria:

  • Does not meet the above criteria.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Lifestyle Intervention

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.
Annen: Attention Control

The attention control participants will receive a home/work organization intervention:

  • Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter.
  • Virtual or weekly phone calls- with a home organization coach with standard prompts.
  • Text messages supporting home/work organization.

Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intervention adherence
Tidsramme: 4 months

Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
4 months
Intervention retention
Tidsramme: 4 months

Number of women who complete the 4-month data collection
4 months
Intervention retention
Tidsramme: 8 months

Number of women who complete the 8-month data collection
8 months
Change in Quality of Life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum Biomarker Inflammation - C-Reactive Protein
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Change from baseline to 4 month

Analyzed by EVE technologies using standard ELISA kits
Change from baseline to 4 month

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
nRNA and Metabolomics - exploratory
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medical College of Wisconsin

Samarbeidspartnere

Loyola University Chicago

Etterforskere

  • Hovedetterforsker: Melinda Stolley, PhD, Principal Investigator

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2022

Primær fullføring (Faktiske)

30. juni 2026

Studiet fullført (Faktiske)

30. juni 2026

Datoer for studieregistrering

Først innsendt

19. februar 2018

Først innsendt som oppfylte QC-kriteriene

28. januar 2019

Først lagt ut (Faktiske)

31. januar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2026

Sist bekreftet

1. april 2025

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 27600

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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