NCT04896580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

April 19, 2021

Last Update Submit

February 24, 2025

Conditions

Keywords

NatureExerciseWalkingPsychosocial Well-Being

Outcome Measures

Primary Outcomes (1)

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

    Feasibility of Nature Walk Programs

    12 weeks

Secondary Outcomes (12)

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

    Measured at Baseline and at Week 12

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

    Measured at Baseline and at Week 12

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

    Measured at Baseline and at Week 12

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

    Measured at Baseline and at Week 12

  • Biologic aging markers

    Measured at Baseline and at Week 12

  • +7 more secondary outcomes

Study Arms (1)

Active

EXPERIMENTAL

Participants will be asked to complete a 12 week exercise program

Behavioral: Nature based exercise

Interventions

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.

Active

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Men and women between age of 18 to 39
  • Previously diagnosed with cancer
  • Below 18 years old
  • Above 39 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90069, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsLymphomaLeukemiaProstatic NeoplasmsThyroid NeoplasmsHematologic NeoplasmsLymphoma, Non-HodgkinMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesBehavior

Study Officials

  • Celina Shirazipour, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
  • Arash Asher, M.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Cedars-Sinai Cancer Research Center for Health Equity

Study Record Dates

First Submitted

April 19, 2021

First Posted

May 21, 2021

Study Start

June 21, 2021

Primary Completion

May 18, 2023

Study Completion

May 18, 2023

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations