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Randomized phase II study of a home-based walking intervention for radiation-related fatigue among older patients with breast cancer.

Journal of geriatric oncology
March 1, 2021
Noam A VanderWalde et al. (10 authors)
Clinical Trial, Phase IIJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of a home-based graduated walking program versus a fixed walking recommendation on fatigue in older women with breast cancer undergoing radiation therapy.

Results Summary

Both walking interventions increased physical activity and improved physical function, but neither significantly reduced fatigue more than the other. However, increased walking over time was associated with lower fatigue levels.

Population

Women aged 65+ with stage 0-3 breast cancer undergoing adjuvant radiotherapy.

Effective Dosage

Mean walking increased from 21 min/week at baseline to 83 min/week by the end of RT.

Duration

Duration of radiation therapy (specific length not stated).

Interactions

None mentioned

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Home-Based Graduated Walking Program (HBGWP)
no change
fatigue
older adult breast cancer patients
-
did not decrease fatigue more than
#1
Home-Based Graduated Walking Program (HBGWP)
increase
walking
older adult breast cancer patients
-
lead to increased walking
#2
fixed walking recommendation
increase
walking
older adult breast cancer patients
-
lead to increased walking
#3
walking
increase
minutes walking per week
participants
mean 21 min/wk. baseline to 83 min/wk. end of RT
increased
#4
walking
increase
physical function
participants
median 10.5 at baseline to 12 at end of RT
improved
#5
Home-Based Graduated Walking Program (HBGWP)
no change
Total Disruption Index (TDI)
participants
2.7 ± 9.9 vs. 1.8 ± 14.0
no significant difference in change
#6
increasing walking over time
decrease
fatigue
-
-2.44+/- 1.04
associated with statistically significant lower levels of
#7
Abstract

BACKGROUND: Fatigue is a common side effect of radiation therapy and can dramatically affect the quality of life in older cancer patients. We compared a home-based graduated walking intervention with a fixed walking recommendation.recommendation to exercise to determine the effects of these interventions during adjuvant radiotherapy (RT) on older women with breast cancer. METHODS: A randomized phase 2 trial in women ≥65 years, with stage 0-3 breast cancer. Prior to initiating breast RT, women were randomized to a Home-Based Graduated Walking Program (HBGWP) or a fixed walking recommendation. The primary outcome of fatigue was measured by the Total Disruption Index (TDI) of the Fatigue Symptom Inventory (FSI). Secondary outcomes including a short physical performance battery (SPPB) and questionnaires on exercise, physical function, fatigue (PROMIS Fatigue), and fatigue-related symptoms were collected at 3 time points. The primary goal was to compare the change in TDI between arms at the end of RT. Random coefficients models were used to determine the association between arm, fatigue, and exercise over time. Linear regression models were used to describe the change in outcome variables between visits. RESULTS: Median age of the 54 participants (27 per arm) was 69 years (range 65-84). The baseline characteristics were similar between study arms. The number of minutes walking per week increased in both arms (mean 21 min/wk. baseline to 83 min/wk. end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± 9.9 vs. 1.8 ± 14.0, p = 0.61)between baseline and end of RT. However, in our linear regression model increasing walking over time was associated with statistically significant lower levels of fatigue (-2.44+/- 1.04, p = 0.04), but not in posthoc subgroup analyses. CONCLUSION: The HBGWP did not decrease fatigue more than the fixed recommendation to exercise. Both the graduated intervention and fixed recommendation lead to increased walking which was associated with lower fatigue in this study of older adult breast cancer patients.

Medical Subject Headings (MeSH)
AgedAged, 80 and overBreast NeoplasmsExerciseExercise TherapyFatigueFemaleHumansQuality of LifeWalking
Study Links
Quality Scores
Safety90
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations14
Citations/Year3.5
Relative Citation Ratio1.58
NIH Percentile66.9%
Research Impact Scores
APT Score0.75
Weight Score2.53
Normalized Score0.80
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