AzTrials
AzTrials

Breast CancerNCT04896580

IIT2020-20-SHIRAZIP-WALK: Nature Walks

A study testing Nature based exercise in people with Breast Cancer and Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Cancer, Lymphoma
What is being tested?
Nature based exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
21 Jun 2021to 18 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90069

Other trials in United States

About this study

Official title: The Benefits of Nature-based Walking for Breast Cancer Survivors: a Pilot Study

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.

Read the 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.

Being tested
Nature based exercise
Keywords
Nature, Exercise, Walking, Psychosocial Well-Being
Medical subject headings
Breast Neoplasms, Neoplasms, Lymphoma, Leukemia, Prostatic Neoplasms, Thyroid Neoplasms, Hematologic Neoplasms, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nature based exerciseBehavioural

    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.

Study groups in NCT04896580
Study groupRoleWhat they receive
ActiveExperimentalParticipants will be asked to complete a 12 week exercise program
Receives: Behavioral: Nature based exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants that adhere to a 3-month nature-based walking program

    Feasibility of Nature Walk Programs

    Measured: 12 weeks

Secondary outcomes (12)

  1. Short-term effects of green space and nature physical activity environments on well-being

    PROMIS-29

    Measured: Measured at Baseline and at Week 12

  2. Short-term effects of green space and nature physical activity environments on social well-being

    PROMIS Social Support

    Measured: Measured at Baseline and at Week 12

  3. Short-term effects of green space and nature physical activity environments on post-trauma growth and self-improvement

    PTGI

    Measured: Measured at Baseline and at Week 12

  4. Short-term effects of green space and nature physical activity environments on physical, social/family, emotional, and functional well-being

    FACT-G

    Measured: Measured at Baseline and at Week 12

  5. Biologic aging markers

    DNA methylation, aging genes

    Measured: Measured at Baseline and at Week 12

  6. TNF-α cytokine

    TNF-α

    Measured: Measured at Baseline and at Week 12

  7. Inflammatory cytokines

    IL-1ß

    Measured: Measured at Baseline and at Week 12

  8. Inflammatory cytokines, anti-inflammatory myokines

    IL-6

    Measured: Measured at Baseline and at Week 12

  9. Inflammatory marker

    CRP

    Measured: Measured at Baseline and at Week 12

  10. TGF-ß cytokine

    TGF-ß

    Measured: Measured at Baseline and at Week 12

  11. Anti-inflammatory cytokine

    IL-10

    Measured: Measured at Baseline and at Week 12

  12. IL-13 cytokine

    IL-13

    Measured: Measured at Baseline and at Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start21 Jun 2021
  3. Primary completion18 May 2023
  4. Study completion18 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896580
Sponsor's protocol ID
STUDY00001356
Status last verified
Feb 2025
First submitted
19 Apr 2021
Last updated
26 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37328178

Questions about this trial

What is this clinical trial studying?

A study testing Nature based exercise in people with Breast Cancer and Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants that adhere to a 3-month nature-based walking program (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04896580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in