The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older



Status:Completed
Conditions:Cancer, Cancer, Other Indications
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:65 - Any
Updated:9/13/2017
Start Date:June 2014
End Date:August 2017

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A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)

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.

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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Hyman B Muss, MD
Phone: 919-843-1906
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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