Young Adult, Cancer, Physical Activity Clinical Trial
Official title:
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Verified date | July 2021 |
Source | University of Wisconsin, Milwaukee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals.
Status | Completed |
Enrollment | 47 |
Est. completion date | July 16, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - have a diagnosis of cancer; - are within the first two months of a chemotherapy regimen that will last at least another 3 months; - are ambulatory without assistance; - have written consent from their physician to participate; - have the ability to understand English; - have access to a computer and the Internet. Exclusion Criteria: - symptoms of uncontrolled cardiopulmonary disease, neurological disease - delayed wound healing - high risk of bone fracture - pre-existing peripheral neuropathy |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Froedtert Hospital | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Milwaukee | Children's Hospital and Health System Foundation, Wisconsin, Froedtert Hospital, Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-efficacy for Physical Activity | Physical Activity Assessment Inventory (Haas & Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do. | Completion of post-study measures (average 15 weeks) | |
Primary | Self-regulation of Physical Activity | Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills. | Completion of post-study measures (average 15 weeks) | |
Secondary | Steps Per Day | Measured by accelerometer | Completion of post-study measures (average 15 weeks) | |
Secondary | Fatigue Severity | Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity. | Completion of end-of-study measures (average 15 weeks) |