Clinical trial NCT04896580: IIT2020-20-SHIRAZIP-WALK: Nature Walks
Official title: The Benefits of Nature-based Walking for Breast Cancer Survivors: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer
Lymphoma
Leukemia
Prostate Cancer
Thyroid Cancer
Hematologic Malignancy
Non-hodgkin Lymphoma
Keywords: Nature
Exercise
Walking
Psychosocial Well-Being
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 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

Primary outcomes:
measure: Number of participants that adhere to a 3-month nature-based walking program
timeFrame: 12 weeks
Secondary outcomes:
measure: Short-term effects of green space and nature physical activity environments on well-being
timeFrame: Measured at Baseline and at Week 12
measure: Short-term effects of green space and nature physical activity environments on social well-being
timeFrame: Measured at Baseline and at Week 12
measure: Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvement
timeFrame: Measured at Baseline and at Week 12
measure: Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-being
timeFrame: Measured at Baseline and at Week 12
measure: Biologic aging markers
timeFrame: Measured at Baseline and at Week 12
measure: TNF-α cytokine
timeFrame: Measured at Baseline and at Week 12
measure: Inflammatory cytokines
timeFrame: Measured at Baseline and at Week 12
measure: Inflammatory cytokines, anti-inflammatory myokines
timeFrame: Measured at Baseline and at Week 12
measure: Inflammatory marker
timeFrame: Measured at Baseline and at Week 12
measure: TGF-ß cytokine
timeFrame: Measured at Baseline and at Week 12
measure: Anti-inflammatory cytokine
timeFrame: Measured at Baseline and at Week 12
measure: IL-13 cytokine
timeFrame: Measured at Baseline and at Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Celina Shirazipour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, M.D.
role: PRINCIPAL_INVESTIGATOR
References: