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

NCT ID: NCT03000166

Last Updated: 2021-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-07-16

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.

Conditions

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Young Adult, Cancer, Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Step-Up Intervention

Intervention Type 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.

Attention Control Group

Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Froedtert Hospital

OTHER

Sponsor Role collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role lead

Responsible Party

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Jeanne M. Erickson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Schiffman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

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Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P20NR015339

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P20NR015339-PP3

Identifier Type: -

Identifier Source: org_study_id

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