NCT02682836

Brief Summary

Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

February 10, 2016

Last Update Submit

January 4, 2022

Conditions

Metastatic Breast Cancer

Keywords

physical activitychemotherapyfatigue

Outcome Measures

Primary Outcomes (1)

  • changes in fatigue scores

    Evaluate change in PROMIS Fatigue scores from baseline to 3 months

    at 3 months

Study Arms (1)

single arm

EXPERIMENTAL

Walk with Ease physical activity intervention

Behavioral: Walk with Ease

Interventions

Walk with EaseBEHAVIORAL
single arm

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age 21 or older
  • Metastatic breast cancer (MBC) diagnosis - Stage IV
  • Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
  • Approval from the treating clinician to engage in moderate-intensity physical activity.
  • Patient-assessed ability to walk and engage in moderate physical activity
  • Proficient in English.
  • IRB approved signed written informed consent.
  • Willing and able to do all study requirements.

You may not qualify if:

  • One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
  • No more than 3 prior chemotherapy regimens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Cancer Hospital

Chapel Hill, North Carolina, 27519, United States

Location

Related Publications (1)

  • Shachar SS, Heiling H, Muss HB, Meghan D, Wagoner CW, Deal AM, Nyrop KA. Physical Activity Intervention in Patients with Metastatic Breast Cancer During Active Treatment: Quality of Life and Function. Oncologist. 2023 Jan 18;28(1):84-e70. doi: 10.1093/oncolo/oyac232.

    PMID: 36398879DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivityFatigue

Interventions

Walkingmethyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Kirsten A Nyrop, PhD

    UNC Lineberger Comprehensive Cancer 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
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

January 6, 2022

Record last verified: 2022-01

Locations

US(1)