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The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older

NCT02434367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-12-14

No results posted yet for this study

Summary

This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.

Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women in both arms will complete a number of surveys including questionnaires on fatigue, pain, depression, sleep, and social support. In addition, a blood sample will be collected prior to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of inflammatory biomarkers, and their potential association with exercise and fatigue.

Conditions

Interventions

BEHAVIORAL

Walk With Ease Arm A

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The interention is a self directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes per day, five days per week.

Sponsors & Collaborators

  • University of Tennessee West Cancer Center

    collaborator OTHER

  • The West Clinic, Memphis

    lead INDUSTRY

Principal Investigators

  • Noam VanderWalde, MD · The West Clinic/University of Tennessee West Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434367 on ClinicalTrials.gov