IIT2020-20-SHIRAZIP-WALK: Nature Walks

NCT ID: NCT04896580

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2023-05-18

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active

Participants will be asked to complete a 12 week exercise program

Group Type EXPERIMENTAL

Nature based exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


1. Men and women between age of 18 to 39
2. Previously diagnosed with cancer

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.


1. Below 18 years old
2. Above 39 years old
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Celina Shirazipour

Assistant Professor, Cedars-Sinai Cancer Research Center for Health Equity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celina Shirazipour, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Arash Asher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Shirazipour CH, Raines C, Liu E, Ruggieri RM, Capaldi JM, Luna-Lupercio B, Diniz MA, Gresham G, Bhowmick N, Haile RW, Asher A. Benefits of nature-based walking for breast cancer survivors. BMJ Open. 2023 Jun 16;13(6):e071041. doi: 10.1136/bmjopen-2022-071041.

Reference Type DERIVED
PMID: 37328178 (View on PubMed)

Other Identifiers

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STUDY00001356

Identifier Type: -

Identifier Source: org_study_id

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