IIT2020-20-SHIRAZIP-WALK: Nature Walks

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Benefits of Nature-based Walking for Breast Cancer Survivors: A Pilot Study

Conditions
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Cancer, Breast Cancer, Lymphoma, Leukemia, Prostate Cancer, Thyroid Cancer, Hematologic Malignancy, Non-hodgkin Lymphoma

Intervention / Treatment
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* Behavioral: Nature based exercise


Participation Criteria
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Eligibility Criteria
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Main Breast Cancer Study Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Participants will be asked to complete a 12 week exercise program | Behavioral: Nature based exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that adhere to a 3-month nature-based walking program | Feasibility of Nature Walk Programs | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term effects of green space and nature physical activity environments on well-being | PROMIS-29 | Measured at Baseline and at Week 12 | 
| Short-term effects of green space and nature physical activity environments on social well-being | PROMIS Social Support | 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 | PTGI | 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 | FACT-G | Measured at Baseline and at Week 12 | 
| Biologic aging markers | DNA methylation, aging genes | Measured at Baseline and at Week 12 | 
| TNF-α cytokine | TNF-α | Measured at Baseline and at Week 12 | 
| Inflammatory cytokines | IL-1ß | Measured at Baseline and at Week 12 | 
| Inflammatory cytokines, anti-inflammatory myokines | IL-6 | Measured at Baseline and at Week 12 | 
| Inflammatory marker | CRP | Measured at Baseline and at Week 12 | 
| TGF-ß cytokine | TGF-ß | Measured at Baseline and at Week 12 | 
| Anti-inflammatory cytokine | IL-10 | Measured at Baseline and at Week 12 | 
| IL-13 cytokine | IL-13 | Measured at Baseline and at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nature, Exercise, Walking, Psychosocial Well-Being