Breast Cancer Clinical Trial
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Men and women age 65 years and older
Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
Moderate to severe fatigue (>4 on BFI)
Less than 120 minutes/week of physical activity
English speaking
Signed IRB approved written informed consent
Approval from their treating physician to engage in moderate-intensity physical activity
Patient-assessed ability to walk and engage in moderate physical activity
Willing and able to meet all study requirements.
Exclusion Criteria:
Receiving hormonal therapy for prostate cancer
Unable to walk or engage in moderate-intensity physical activity
Have BFI≤3.
Report more than 120 minutes/week of physical activity
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There is 1 Location for this study
Chapel Hill North Carolina, 27599, United States
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