Back to resultsStep-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Primary Purpose
Young Adult, Cancer, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Step-Up Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Young Adult, Cancer, Physical Activity
Eligibility Criteria
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
Sites / Locations
- Froedtert Hospital
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Step-Up Intervention Group
Attention Control Group
Arm Description
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.
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Steps Per Day
Measured by accelerometer
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.
Full Information
NCT ID
NCT03000166
First Posted
December 15, 2016
Last Updated
July 19, 2021
Sponsor
University of Wisconsin, Milwaukee
Collaborators
Froedtert Hospital, Children's Hospital and Health System Foundation, Wisconsin, Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT03000166
Brief Title
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Official Title
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
Froedtert Hospital, Children's Hospital and Health System Foundation, Wisconsin, Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Young Adult, Cancer, Physical Activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Step-Up Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control Group
Arm Type
No Intervention
Arm Description
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
Intervention Type
Behavioral
Intervention Name(s)
Step-Up Intervention
Intervention Description
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 Outcome Measure Information:
Title
Self-efficacy for Physical Activity
Description
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.
Time Frame
Completion of post-study measures (average 15 weeks)
Title
Self-regulation of Physical Activity
Description
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.
Time Frame
Completion of post-study measures (average 15 weeks)
Secondary Outcome Measure Information:
Title
Steps Per Day
Description
Measured by accelerometer
Time Frame
Completion of post-study measures (average 15 weeks)
Title
Fatigue Severity
Description
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.
Time Frame
Completion of end-of-study measures (average 15 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Schiffman, PhD
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
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