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Completed

NCT Number: NCT04896580

IIT2020-20-SHIRAZIP-WALK: Nature Walks

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nature based exercise

Behavioral

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.

Primary outcomes

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

    Time frame: 12 weeks

    Feasibility of Nature Walk Programs

Secondary outcomes

  1. Short-term effects of green space and nature physical activity environments on well-being

    Time frame: Measured at Baseline and at Week 12

    PROMIS-29

  2. Short-term effects of green space and nature physical activity environments on social well-being

    Time frame: Measured at Baseline and at Week 12

    PROMIS Social Support

  3. Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvement

    Time frame: Measured at Baseline and at Week 12

    PTGI

  4. Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-being

    Time frame: Measured at Baseline and at Week 12

    FACT-G

  5. Biologic aging markers

    Time frame: Measured at Baseline and at Week 12

    DNA methylation, aging genes

  6. TNF-α cytokine

    Time frame: Measured at Baseline and at Week 12

    TNF-α

  7. Inflammatory cytokines

    Time frame: Measured at Baseline and at Week 12

    IL-1ß

  8. Inflammatory cytokines, anti-inflammatory myokines

    Time frame: Measured at Baseline and at Week 12

    IL-6

  9. Inflammatory marker

    Time frame: Measured at Baseline and at Week 12

    CRP

  10. TGF-ß cytokine

    Time frame: Measured at Baseline and at Week 12

    TGF-ß

  11. Anti-inflammatory cytokine

    Time frame: Measured at Baseline and at Week 12

    IL-10

  12. IL-13 cytokine

    Time frame: Measured at Baseline and at Week 12

    IL-13

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 21, 2021
Registry last updated
Feb 26, 2025

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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