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NCT00572416 · ClinicalTrials.gov registry record · NA

Fatigue in Breast Cancer: A Behavioral Sleep Intervention

A NA study, sponsored by University of Nebraska.

Completed
Registry status
NA
Development phase
220
Enrollment target

NCT00572416: Completed NA study, sponsored by University of Nebraska.

NCT00572416 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 220 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00572416, a NA study, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
NA
Development phase
220 participants
Enrollment target

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

Primary Outcome

Fatigue as measured by Piper Fatigue Scale

Interventions

  • BEHAVIORAL Healthy Eating Control
  • BEHAVIORAL Individual Sleep Promotion Plan

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2003-04-01
Est. Completion 2006-06-01
Phase NA
University of Nebraska

407 total trials

What the finished NCT00572416 record still lists

NCT00572416 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Healthy Eating Control is the first listed.

NCT00572416 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00572416 about?

NCT00572416 is a clinical study titled "Fatigue in Breast Cancer: A Behavioral Sleep Intervention". 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 ...

What is the current status of trial NCT00572416?

This trial is currently completed. It is a NA study. The enrollment target is 220 participants. The study started on 2003-04-01. Estimated completion is 2006-06-01.

What interventions are being tested in trial NCT00572416?

The interventions under investigation include: Healthy Eating Control (BEHAVIORAL), Individual Sleep Promotion Plan (BEHAVIORAL).

Who is sponsoring clinical trial NCT00572416?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00572416's enrollment target sits among peer trials

220 481st of 2000 higher than 1,516 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00572416, the US trial registry maintained by the National Library of Medicine. NCT00572416 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.