Cedars-Sinai Medical Center
Los Angeles, California, 90069, United States
NCT Number: NCT04896580
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Los Angeles, California, 90069, United States
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).
SUB-STUDY Adolescent and young adult (AYA) (ages 18-39) survivors (n=20) will complete all of the components of the Main-Study described above.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Breast Cancer Study Inclusion Criteria:
Main Breast Cancer Study Exclusion Criteria:
Sub-study AYA Inclusion Criteria:
Sub-Study AYA Exclusion Criteria:
Participants will engage in three months of moderate intensity PA, consisting of three 50-minute walking sessions per week (5-minute warm-up, 40 minute walk, 5 minute cool-down and stretch) with an exercise physiologist for 12 weeks.
Time frame: 12 weeks
Feasibility of Nature Walk Programs
Time frame: Measured at Baseline and at Week 12
PROMIS-29
Time frame: Measured at Baseline and at Week 12
PROMIS Social Support
Time frame: Measured at Baseline and at Week 12
PTGI
Time frame: Measured at Baseline and at Week 12
FACT-G
Time frame: Measured at Baseline and at Week 12
DNA methylation, aging genes
Time frame: Measured at Baseline and at Week 12
TNF-α
Time frame: Measured at Baseline and at Week 12
IL-1ß
Time frame: Measured at Baseline and at Week 12
IL-6
Time frame: Measured at Baseline and at Week 12
CRP
Time frame: Measured at Baseline and at Week 12
TGF-ß
Time frame: Measured at Baseline and at Week 12
IL-10
Time frame: Measured at Baseline and at Week 12
IL-13
Cedars-Sinai Medical Center
Other
The Benefits of Nature-based Walking for Breast Cancer Survivors: a Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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