IIT2020-20-SHIRAZIP-WALK: Nature Walks

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04896580
• Other study ID #: STUDY00001356
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer
• Hematologic Malignancy
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Non-hodgkin Lymphoma
• Prostate Cancer
• Thyroid Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that adhere to a 3-month nature-based walking program	Feasibility of Nature Walk Programs	12 weeks
Secondary	Short-term effects of green space and nature physical activity environments on well-being	PROMIS-29	Measured at Baseline and at Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Biologic aging markers	DNA methylation, aging genes	Measured at Baseline and at Week 12
Secondary	TNF-a cytokine	TNF-a	Measured at Baseline and at Week 12
Secondary	Inflammatory cytokines	IL-1ß	Measured at Baseline and at Week 12
Secondary	Inflammatory cytokines, anti-inflammatory myokines	IL-6	Measured at Baseline and at Week 12
Secondary	Inflammatory marker	CRP	Measured at Baseline and at Week 12
Secondary	TGF-ß cytokine	TGF-ß	Measured at Baseline and at Week 12
Secondary	Anti-inflammatory cytokine	IL-10	Measured at Baseline and at Week 12
Secondary	IL-13 cytokine	IL-13	Measured at Baseline and at Week 12