The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older
NCT ID: NCT02434367
Last Updated: 2017-12-14
Study Results
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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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2014-08-31
2017-06-30
Brief Summary
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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.
Detailed Description
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Contact with study participants will be at 3 points in time after enrollment and randomization:
Baseline: At this meeting, requirements of the study will be reviewed, and study materials provided (for control arm: a one page explanation discussing the potential benefits of exercise on fatigue, for experimental arm: WWE workbook, and printed walking log). Participants will complete questionnaires and undergo other assessments including a blood draw. For those on the experimental arm, they will be asked to begin the walking program within a week, noting their walking experience in their daily log.
Last week of radiation: All participants will repeat questionnaires and other assessments during any day of their last week of radiation. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed. For those receiving hypofractionated radiotherapy, this will occur at week 4. For those receiving standard fractionation this will occur at week 6.
4-6 weeks following end of radiation: All participants will repeat questionnaires and other assessments. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed.
Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy. The sheet will summarize the findings of the 3 randomized studies on exercise intervention during radiotherapy.
The primary activity required of study subjects is a 4-6-week self-directed (non-group) WWE walking program that participants do at a place and time that is convenient for them. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Arm A
Women randomized to the WWE program will receive a workbook, and a daily walking log, the latter to be completed during the study.
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.
Arm B
Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Stage I, II or III breast cancer status post breast surgery with or without adjuvant chemotherapy.
* Scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall.
* English speaking.
* IRB approved, signed written informed consent.
* Approval from their treating radiation oncologist to engage in moderate-intensity physical activity. This will be obtained by the study research coordinator and documented on the study screening form (attached).
* Patient-assessed ability to walk and engage in moderate physical activity Willing and able to meet all study requirements.
Exclusion Criteria
* Receiving accelerated partial breast irradiation.
* Unable to walk or engage in moderate-intensity physical activity.
* Already participated in Walk with Ease Program.
* Already actively walking (≥120 minutes per week).
65 Years
FEMALE
No
Sponsors
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University of Tennessee West Cancer Center
OTHER
The West Clinic, Memphis
INDUSTRY
Responsible Party
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Principal Investigators
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Noam VanderWalde, MD
Role: PRINCIPAL_INVESTIGATOR
The West Clinic/University of Tennessee West Cancer Center
Locations
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
The West Clinic/ University of Tennesee West Cancer Center
Memphis, Tennessee, United States
Countries
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Other Identifiers
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LCCC 1412
Identifier Type: -
Identifier Source: org_study_id