하루하루가 중요합니다: 전이성 유방암이 있는 여성을 위한 라이프스타일 프로그램 (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).
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Maywood, Illinois, 미국, 60153
- Loyola University
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
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다른: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intervention adherence
기간: 4 months
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Number of lifestyle coaching sessions completed out of a possible total of 16 sessions |
4 months
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Intervention retention
기간: 4 months
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Number of women who complete the 4-month data collection |
4 months
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Intervention retention
기간: 8 months
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Number of women who complete the 8-month data collection |
8 months
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Change in Quality of Life
기간: Change from baseline to 4 months
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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
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Change in Quality of Life
기간: change from baseline to 8 months
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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
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Body composition
기간: change from baseline to 4 months
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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
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Body composition
기간: change from baseline to 8 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Biomarker Inflammation - C-Reactive Protein
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Insulin Resistance - Insulin
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Insulin Resistance- Glucose
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Insulin Resistance- C-Peptide
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Adipokine Dysregulation - Adiponectin
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Adipokine Dysregulation - Leptin
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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Serum Biomarker Inflammation - Interleukin 6
기간: Change from baseline to 4 month
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Analyzed by EVE technologies using standard ELISA kits |
Change from baseline to 4 month
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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nRNA and Metabolomics - exploratory
기간: Baseline to 3 months
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Melinda Stolley, PhD, Principal Investigator
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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