This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.
The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention 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 a day, five days a week.
University of North Carolina
Chapel Hill, North Carolina, United States
To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
Change in fatigue will be measured using the FACIT-F.
Time frame: Three months
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
This outcome will be measured by the Brief Fatigue Inventory
Time frame: Three months
To report recruitment and retention in the study at 3 months
Time frame: Three months
To report recruitment and retention in the study at 6 months
Time frame: Six months
To measure implementation of and adherence to WWE
Time frame: Six months
To count the number of adverse events
To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
Time frame: Six months
To measure change in engagement of walking over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Time frame: Three Months
To measure change in physical function over time from baseline to three months.
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Physical function as measured by SPPB
Time frame: Three Months
To measure change in quality of life over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.
Time frame: Three Months
To measure change in self-efficacy over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Time frame: Three Months