IIT2020-20-SHIRAZIP-WALK: Nature Walks
Study Details
Study Description
Brief Summary
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 this study. The study will enroll up to 20 people in total.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a single arm pilot 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).
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. During COVID pandemic, sessions will be socially distanced one-on-one with an EP. After the pandemic, they will take place in small groups (3-5 participants). Participants will be encouraged to keep the same days and walk session times throughout the intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Participants will be asked to complete a 12 week exercise program |
Behavioral: Nature based exercise
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.
|
Outcome Measures
Primary Outcome Measures
- Number of participants that adhere to a 3-month nature-based walking program [12 weeks]
Feasibility of Nature Walk Programs
Secondary Outcome Measures
- Short-term effects of green space and nature physical activity environments on well-being [Measured at Baseline and at Week 12]
PROMIS-29
- Short-term effects of green space and nature physical activity environments on social well-being [Measured at Baseline and at Week 12]
PROMIS Social Support
- 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]
PTGI
- 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]
FACT-G
- Biologic aging markers [Measured at Baseline and at Week 12]
DNA methylation, aging genes
- TNF-α cytokine [Measured at Baseline and at Week 12]
TNF-α
- Inflammatory cytokines [Measured at Baseline and at Week 12]
IL-1ß
- Inflammatory cytokines, anti-inflammatory myokines [Measured at Baseline and at Week 12]
IL-6
- Inflammatory marker [Measured at Baseline and at Week 12]
CRP
- TGF-ß cytokine [Measured at Baseline and at Week 12]
TGF-ß
- Anti-inflammatory cytokine [Measured at Baseline and at Week 12]
IL-10
- IL-13 cytokine [Measured at Baseline and at Week 12]
IL-13
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female previously diagnosed with breast cancer (clinical stages 1 - 3)
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Minimum of 3 months post-active treatment completion
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Maximum of 21 months post-active treatment completion
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Physically able to complete baseline fitness assessments (e.g., 6-minute walk test, hand grip test, 1 RM leg press)
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Ambulatory without assistance
Exclusion Criteria:
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Active treatment planned within the next 6 months.
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Known metastatic disease.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90069 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
- Principal Investigator: Celina Shirazipour, PhD, Cedars-Sinai Medical Center
- Principal Investigator: Arash Asher, M.D., Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00001356