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Fatigue in Breast Cancer: A Behavioral Sleep Intervention

NCT00572416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-08-31

No results posted yet for this study

Summary

1. This randomized clinical trial compares a four component behavioral sleep intervention group to an attention control healthy eating group
2. The behavioral sleep intervention is designed to reduce fatigue in women with stages I-IIIA breast cancer receiving anthracycline-based chemotherapy
3. The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and nighttime sleep,and to decrease physchological and symptom distress
4. The healthy eating group receives equal time and attention and information on healthy eating
5. All participants receive a research nurse visit 2 days prior to each chemotherapy treatment, and 30, 60, 90 days after the last treatment, and one-year after the first treatment.
6. Adherence to the intervention is calculated at each time
7. Reliable and valid instruments are used, including wrist actigraphy

Conditions

Interventions

BEHAVIORAL

Individual Sleep Promotion Plan

Four components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene

BEHAVIORAL

Healthy Eating Control

Equal time and attention and information about healthy eating

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Ann M Berger, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-01
Completion
2006-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572416 on ClinicalTrials.gov