NCT00572416

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2003

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

First QC Date

December 11, 2007

Last Update Submit

August 28, 2023

Conditions

Breast Cancer

Keywords

fatigueactivity-restsleep-wakepsychological distresssymptom management

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Fatigue as measured by Piper Fatigue Scale

    1 year

Secondary Outcomes (4)

  • Activity-rest as measured by SF-36v2 and actigraphy

    1 year

  • Sleep-wake

    1 year

  • Psychological mood

    1 year

  • Symptom experience

    1 year

Study Arms (2)

1 Individual Sleep Promotion Plan

EXPERIMENTAL

Four component behavioral sleep intervention comprised of activity-rest, sleep-wake, psychological distress and symptom management. Four components of the Individual Sleep Promotion Plan are: stimulus control, sleep restruction, relaxation, and sleep hygiene.

Behavioral: Individual Sleep Promotion Plan

2 Healthy Eating Control

PLACEBO COMPARATOR

Equal time and attention, information about healthy eating and general conversation

Behavioral: Healthy Eating Control

Interventions

Individual Sleep Promotion PlanBEHAVIORAL

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

1 Individual Sleep Promotion Plan
Healthy Eating ControlBEHAVIORAL

Equal time and attention and information about healthy eating

2 Healthy Eating Control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 19 and older
  • Diagnosed for the first time with stage I-IIIA breast cancer
  • Post-operative for breast cancer
  • Scheduled to receive anthracycline-based adjuvant chemotherapy with our without taxane chemotherapy
  • English speaking
  • Karnofsky performance Scale score equal to or greater than 60

You may not qualify if:

  • Comorbid diagnosis of chronic insomnia
  • Sleep apnea or chronic fatigue syndrome
  • Unstable congestive heart failure
  • Chronic obstructive pulmonary disease
  • Insulin-depenent diabetes
  • Neruomuscular disease
  • Abnormal thryoid function
  • Depression, or
  • Treatment with steriods
  • Erratic sleep schedule due to working rotating shifts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (2)

  • Berger AM, Farr LA, Kuhn BR, Fischer P, Agrawal S. Values of sleep/wake, activity/rest, circadian rhythms, and fatigue prior to adjuvant breast cancer chemotherapy. J Pain Symptom Manage. 2007 Apr;33(4):398-409. doi: 10.1016/j.jpainsymman.2006.09.022.

    PMID: 17397701RESULT

  • Berger AM, Neumark DE, Chamberlain J. Enhancing recruitment and retention in randomized clinical trials of cancer symptom management. Oncol Nurs Forum. 2007 Mar;34(2):E17-22. doi: 10.1188/07.ONF.E17-E22.

    PMID: 17573292RESULT

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann M Berger, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

April 1, 2003

Study Completion

June 1, 2006

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

US(1)