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.

Study Overview

• Status: Completed
• Conditions: Young Adult, Cancer, Physical Activity
• Intervention / Treatment: Behavioral: Step-Up Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital
    • Milwaukee, Wisconsin, United States, 53233
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Step-Up Intervention Group; Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.	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.
No Intervention: Attention Control Group; Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps Per Day	Measured by accelerometer	Completion of post-study measures (average 15 weeks)
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Collaborators: Medical College of Wisconsin; Children's Hospital and Health System Foundation, Wisconsin; Froedtert Hospital
• Investigators: Principal Investigator: Rachel Schiffman, PhD, University of Wisconsin, Milwaukee

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 17, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: P20NR015339-PP3; P20NR015339 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No