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

U

University of Wisconsin, Milwaukee

Status

Completed

Conditions

Young Adult, Cancer, Physical Activity

Treatments

Behavioral: Step-Up Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03000166
P20NR015339 (U.S. NIH Grant/Contract)
P20NR015339-PP3

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

Step-Up Intervention Group
Experimental group
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.
Treatment:
Behavioral: Step-Up Intervention
Attention Control Group
No Intervention group
Description:
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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