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

NCT03000166 | Completed Results DMC

• 2 other identifiers: P20NR015339-PP3P20NR015339
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Young Adult, Cancer, Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Steps Per Day

  Completion of post-study measures (average 15 weeks)

• Fatigue Severity

  Completion of end-of-study measures (average 15 weeks)

Study Arms (2)

Step-Up Intervention Group

EXPERIMENTAL

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

Attention Control Group

NO INTERVENTION

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

Interventions

Step-Up Intervention 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.

Step-Up Intervention Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• symptoms of uncontrolled cardiopulmonary disease, neurological disease
• delayed wound healing
• high risk of bone fracture
• pre-existing peripheral neuropathy

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• Froedtert Hospital: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (2)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Jeanne M. Erickson, PhD, RN
• Organization: University of Wisconsin-Milwaukee

ericksoj@uwm.edu

414-229-6920

Study Officials

• Rachel Schiffman, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 21, 2016
• Study Start: January 31, 2017
• Primary Completion: May 1, 2019
• Study Completion: July 16, 2019
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)