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IIT2020-20-SHIRAZIP-WALK: Nature Walks

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04896580
Enrollment
20
Registered
2021-05-21
Start date
2021-06-21
Completion date
2023-05-18
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Nature, Exercise, Walking, Psychosocial Well-Being

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 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

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.

Interventions

BEHAVIORALNature 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.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Main Breast Cancer Study Inclusion Criteria: 1. Female previously diagnosed with breast cancer (clinical stages 1 - 3) 2. Minimum of 3 months post-active treatment completion 3. Maximum of 21 months post-active treatment completion 4. Physically able to complete baseline fitness assessments (e.g., 6-minute walk test, hand grip test, 1 RM leg press) 5. Ambulatory without assistance Main Breast Cancer Study

Exclusion criteria

1. Active treatment planned within the next 6 months. 2. Known metastatic disease. 3. Currently meeting physical activity guidelines (score of \>23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire). 4. Known allergy to Fitbit device or otherwise unable to wear Fitbit device. Sub-study AYA Inclusion Criteria: 1. Men and women between age of 18 to 39 2. Previously diagnosed with cancer 3. Same inclusion criteria as the main study Sub-Study AYA

Design outcomes

Primary

MeasureTime frameDescription
Number of participants that adhere to a 3-month nature-based walking program12 weeksFeasibility of Nature Walk Programs

Secondary

MeasureTime frameDescription
Short-term effects of green space and nature physical activity environments on social well-beingMeasured at Baseline and at Week 12PROMIS Social Support
Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvementMeasured at Baseline and at Week 12PTGI
Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-beingMeasured at Baseline and at Week 12FACT-G
Biologic aging markersMeasured at Baseline and at Week 12DNA methylation, aging genes
TNF-α cytokineMeasured at Baseline and at Week 12TNF-α
Short-term effects of green space and nature physical activity environments on well-beingMeasured at Baseline and at Week 12PROMIS-29
Inflammatory cytokines, anti-inflammatory myokinesMeasured at Baseline and at Week 12IL-6
Inflammatory markerMeasured at Baseline and at Week 12CRP
TGF-ß cytokineMeasured at Baseline and at Week 12TGF-ß
Anti-inflammatory cytokineMeasured at Baseline and at Week 12IL-10
IL-13 cytokineMeasured at Baseline and at Week 12IL-13
Inflammatory cytokinesMeasured at Baseline and at Week 12IL-1ß

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026