跳至主要内容
临床试验/NCT04896580
NCT04896580已完成不适用

The Benefits of Nature-based Walking for Breast Cancer Survivors: a Pilot Study

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Number of participants that adhere to a 3-month nature-based walking program

研究概览

简要总结

The purpose of this study is to examine whether nature-based activities provide benefits for breast cancer survivors. The investigators want to know whether a nature-based exercise program is feasible. Women who were diagnosed with breast cancer and have completed cancer treatment will be recruited for the main study. The main study will enroll up to 20 breast cancer subjects in total.

This intervention will also include a sub-study examining the same outcomes among adolescents and young adult (AYA) subjects who were diagnosed with cancer (any type) and have completed cancer treatment. The sub-study will enroll up to 20 AYA (ages 18-39) subjects.

详细描述

This is a single-arm pilot study

MAIN STUDY Breast cancer survivors (n=20) will engage in three months of moderate intensity walking sessions three times a week in a nature and park conservation area. All walks will be supervised by certified clinical Exercise Physiologists (EP). Participants will be encouraged to keep the same days and walk session times throughout the intervention.

Sessions will be 50-minutes in total (5-minute warm-up, 40 minute walk, 5 minute cool-down and stretch). Session intensity will be tracked with Fitbits. Participants will be asked to reach a moderate intensity heart rate, defined as 40%-59% heart rate reserve.

Participants will complete surveys, physical assessments and collection of biomarkers at baseline and at end of study. Participants also have the option to participate in a 1 hr qualitative exit interview about their participation experiences.

Note. Based on any COVID pandemic restrictions at the time of a walk, sessions will be socially distanced one-on-one with an EP. When no restrictions are in place, they will take place in small groups (3-5 participants).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female previously diagnosed with breast cancer (clinical stages 1 - 3)
  • Minimum of 3 months post-active treatment completion
  • Maximum of 21 months post-active treatment completion
  • Physically able to complete baseline fitness assessments (e.g., 6-minute walk test, hand grip test, 1 RM leg press)
  • Ambulatory without assistance
  • Main Breast Cancer Study

排除标准

  • Active treatment planned within the next 6 months.
  • Known metastatic disease.
  • Currently meeting physical activity guidelines (score of >23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire).
  • Known allergy to Fitbit device or otherwise unable to wear Fitbit device.
  • Sub-study AYA Inclusion Criteria:
  • Men and women between age of 18 to 39
  • Previously diagnosed with cancer
  • Same inclusion criteria as the main study
  • Sub-Study AYA Exclusion Criteria:
  • Below 18 years old
  • Above 39 years old
  • Same Exclusion criteria as the main study except for no activity level cutoff score on Godin-Shephard Leisure-Time Physical Activity Questionnaire

结局指标

主要结局

Number of participants that adhere to a 3-month nature-based walking program

时间窗: 12 weeks

Feasibility of Nature Walk Programs

次要结局

  • TGF-ß cytokine(Measured at Baseline and at Week 12)
  • Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvement(Measured at Baseline and at Week 12)
  • Biologic aging markers(Measured at Baseline and at Week 12)
  • Anti-inflammatory cytokine(Measured at Baseline and at Week 12)
  • IL-13 cytokine(Measured at Baseline and at Week 12)
  • Short-term effects of green space and nature physical activity environments on well-being(Measured at Baseline and at Week 12)
  • TNF-α cytokine(Measured at Baseline and at Week 12)
  • Inflammatory marker(Measured at Baseline and at Week 12)
  • Short-term effects of green space and nature physical activity environments on social well-being(Measured at Baseline and at Week 12)
  • Inflammatory cytokines, anti-inflammatory myokines(Measured at Baseline and at Week 12)
  • Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-being(Measured at Baseline and at Week 12)
  • Inflammatory cytokines(Measured at Baseline and at Week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celina Shirazipour

Assistant Professor, Cedars-Sinai Cancer Research Center for Health Equity

Cedars-Sinai Medical Center

研究点 (2)

Loading locations...

相似试验