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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000166
Other study ID # P20NR015339-PP3
Secondary ID P20NR015339
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2017
Est. completion date July 16, 2019

Study information

Verified date July 2021
Source University of Wisconsin, Milwaukee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Interventions to increase physical activity have been shown to relieve fatigue in patients receiving chemotherapy, but no studies have tested a physical activity intervention to improve fatigue in young adults receiving chemotherapy. This study will determine the impact of a physical activity intervention on the self-management process variables of self-efficacy and self-regulation and their relationships to physical activity and fatigue severity in young adults receiving chemotherapy.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Fatigue
  • Young Adult, Cancer, Physical Activity

Intervention

Behavioral:
Step-Up Intervention
Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.

Locations

Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Froedtert Hospital Milwaukee Wisconsin

Sponsors (4)

Lead Sponsor Collaborator
University of Wisconsin, Milwaukee Children's Hospital and Health System Foundation, Wisconsin, Froedtert Hospital, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

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)