IIT2020-20-SHIRAZIP-WALK: Nature Walks

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia; Cancer; Breast Cancer; Prostate Cancer; Hematologic Malignancy; Thyroid Cancer; Non-hodgkin Lymphoma
• Intervention / Treatment: Behavioral: Nature based exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90069
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Exclusion Criteria:

1. Below 18 years old
2. Above 39 years old
3. Same Exclusion criteria as the main study except for no activity level cutoff score on Godin-Shephard Leisure-Time Physical Activity Questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Walking; Nature; Psychosocial Well-Being
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Skin Diseases; Breast Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Neoplasms; Breast Neoplasms; Lymphoma
• Other Study ID Numbers: STUDY00001356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No