Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors

NCT04160182 | Withdrawn

• 1 other identifier: UT BCS ECS Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.

Conditions

Breast Cancer; Fatigue

Keywords

Breast cancer; fatigue; Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Scores (Revised Piper Fatigue Scale)

  Measure of fatigue severity and impact

  Baseline to 14 weeks

Secondary Outcomes (3)

• Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)

  Baseline to 14 weeks

• Change in Fatigue Impact (Modified Fatigue Impact Scale)

  Baseline at 14 weeks

• Change in Severity of Fatigue Measured Via Ecological Momentary Assessments

  Baseline to 14 weeks

Study Arms (1)

Energy Conservation Work Simplification Education

EXPERIMENTAL

The intervention will be delivered online by an occupational therapist. The intervention consists of 6 weekly sessions; each session will be 45 minutes long. The focus of the intervention is to teach breast cancer survivors strategies to manage their fatigue.

Behavioral: Energy Conservation Work Simplification Education

Interventions

Energy Conservation Work Simplification Education BEHAVIORAL

The intervention will last approximately 45 minutes, and will be provided once/week for 6 weeks. The intervention is delivered "live" using web-cameras (e.g., Microsoft Zoom). Registered and licensed occupational therapists will deliver the intervention. At beginning of the intervention, the participant and interventionist prioritize the 5 most critical fatigue-related problems that they would like to solve during the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge and examples on how to apply the knowledge to everyday fatigue-related problems. The workbook contains: (a) information regarding fatigue in breast cancer survivors, (b) knowledge regarding fatigue management strategies, and (c) worksheets to develop skills to recognize and solve fatigue-related problems. Participants will retain the workbook after study completion.

Energy Conservation Work Simplification Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer diagnoses
• not currently receiving active treatment in the form of chemotherapy or radiation therapy
• at least 18 years of age
• fatigue severe enough to limit daily activities (score ≥ 4 on 7-point Fatigue Severity Scale)(Krupp, LaRocca, Muir-Nash, \& Steinberg, 1989);
• functional English fluency and literacy;
• Participant has a smart device that operates on the Android or Apple platform
• Participant is able to use the Ecological Momentary Assessment application before going to bed every night

You may not qualify if:

• self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment,
• Disability due to a diagnosis other then breast cancer
• Currently taking medication for depression, sleep issues, or fatigue.

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead
• University of Toledo: collaborator

Study Sites (1)

University of Toledo

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ketki Raina, PhD, OTR/L

  University of Toledo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 12, 2019
• Study Start: January 27, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)