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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Young Adult, Cancer, Physical Activity

Intervention / Treatment
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* Behavioral: Step-Up Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step-Up Intervention Group<br>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<br>* 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.<br>|
| No Intervention: Attention Control Group<br>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?
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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) |