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IIT2020-20-SHIRAZIP-WALK: Nature Walks

Primary Purpose

Breast Cancer, Cancer, Lymphoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nature based exercise
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Nature, Exercise, Walking, Psychosocial Well-Being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Participants will be asked to complete a 12 week exercise program

Outcomes

Primary Outcome Measures

Number of participants that adhere to a 3-month nature-based walking program
Feasibility of Nature Walk Programs

Secondary Outcome Measures

Short-term effects of green space and nature physical activity environments on well-being
PROMIS-29
Short-term effects of green space and nature physical activity environments on social well-being
PROMIS Social Support
Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvement
PTGI
Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-being
FACT-G
Biologic aging markers
DNA methylation, aging genes
TNF-α cytokine
TNF-α
Inflammatory cytokines
IL-1ß
Inflammatory cytokines, anti-inflammatory myokines
IL-6
Inflammatory marker
CRP
TGF-ß cytokine
TGF-ß
Anti-inflammatory cytokine
IL-10
IL-13 cytokine
IL-13

Full Information

First Posted
April 19, 2021
Last Updated
August 28, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04896580
Brief Title
IIT2020-20-SHIRAZIP-WALK: Nature Walks
Official Title
The Benefits of Nature-based Walking for Breast Cancer Survivors: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer, Lymphoma, Leukemia, Prostate Cancer, Thyroid Cancer, Hematologic Malignancy, Non-hodgkin Lymphoma
Keywords
Nature, Exercise, Walking, Psychosocial Well-Being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Participants will be asked to complete a 12 week exercise program
Intervention Type
Behavioral
Intervention Name(s)
Nature based exercise
Intervention Description
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 Outcome Measure Information:
Title
Number of participants that adhere to a 3-month nature-based walking program
Description
Feasibility of Nature Walk Programs
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Short-term effects of green space and nature physical activity environments on well-being
Description
PROMIS-29
Time Frame
Measured at Baseline and at Week 12
Title
Short-term effects of green space and nature physical activity environments on social well-being
Description
PROMIS Social Support
Time Frame
Measured at Baseline and at Week 12
Title
Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvement
Description
PTGI
Time Frame
Measured at Baseline and at Week 12
Title
Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-being
Description
FACT-G
Time Frame
Measured at Baseline and at Week 12
Title
Biologic aging markers
Description
DNA methylation, aging genes
Time Frame
Measured at Baseline and at Week 12
Title
TNF-α cytokine
Description
TNF-α
Time Frame
Measured at Baseline and at Week 12
Title
Inflammatory cytokines
Description
IL-1ß
Time Frame
Measured at Baseline and at Week 12
Title
Inflammatory cytokines, anti-inflammatory myokines
Description
IL-6
Time Frame
Measured at Baseline and at Week 12
Title
Inflammatory marker
Description
CRP
Time Frame
Measured at Baseline and at Week 12
Title
TGF-ß cytokine
Description
TGF-ß
Time Frame
Measured at Baseline and at Week 12
Title
Anti-inflammatory cytokine
Description
IL-10
Time Frame
Measured at Baseline and at Week 12
Title
IL-13 cytokine
Description
IL-13
Time Frame
Measured at Baseline and at Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celina Shirazipour, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arash Asher, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IIT2020-20-SHIRAZIP-WALK: Nature Walks

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