Skip to main content
OpenTrials
Completed

NCT Number: NCT03000166

Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Young Adult, Cancer, Physical Activity Behavior Motor Activity Neoplasms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step-Up Intervention

Behavioral

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.

Primary outcomes

  1. Self-efficacy for Physical Activity

    Time frame: Completion of post-study measures (average 15 weeks)

    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.

  2. Self-regulation of Physical Activity

    Time frame: Completion of post-study measures (average 15 weeks)

    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.

Secondary outcomes

  1. Steps Per Day

    Time frame: Completion of post-study measures (average 15 weeks)

    Measured by accelerometer

  2. Fatigue Severity

    Time frame: Completion of end-of-study measures (average 15 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin
  • Froedtert Hospital
  • Medical College of Wisconsin

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2016
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.