IIT2020-20-SHIRAZIP-WALK: Nature Walks

Not Applicable

Completed

• Conditions: Lymphoma; Prostate Cancer; Cancer; Leukemia; Breast Cancer; Thyroid Cancer; Hematologic Malignancy; Non-hodgkin Lymphoma
• Interventions: Behavioral: Nature based exercise

• Registration Number: NCT04896580
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Study Start: 2021-06-21
• Primary Completion: 2023-05-18
• Study Completion: 2023-05-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	Nature based exercise	Participants will be asked to complete a 12 week exercise program

Primary Outcome Measures

Name	Time	Method
Number of participants that adhere to a 3-month nature-based walking program	12 weeks	Feasibility of Nature Walk Programs

Secondary Outcome Measures

Name	Time	Method
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
Biologic aging markers	Measured at Baseline and at Week 12	DNA methylation, aging genes
Anti-inflammatory cytokine	Measured at Baseline and at Week 12	IL-10
Short-term effects of green space and nature physical activity environments on well-being	Measured at Baseline and at Week 12	PROMIS-29
TNF-α cytokine	Measured at Baseline and at Week 12	TNF-α
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
Inflammatory cytokines, anti-inflammatory myokines	Measured at Baseline and at Week 12	IL-6
TGF-ß cytokine	Measured at Baseline and at Week 12	TGF-ß
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
Inflammatory cytokines	Measured at Baseline and at Week 12	IL-1ß
Inflammatory marker	Measured at Baseline and at Week 12	CRP
IL-13 cytokine	Measured at Baseline and at Week 12	IL-13

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States