Clinical trial · Interventional
Fatigue in Breast Cancer: A Behavioral Sleep Intervention
Fatigue in Breast Cancer:A Behavioral Sleep Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthy Eating Control | Behavioral | — | UNRESOLVED |
| Individual Sleep Promotion Plan | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1 Individual Sleep Promotion Plan
- description
- 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.
- interventionNames
- Behavioral: Individual Sleep Promotion Plan
- type
- PLACEBO_COMPARATOR
- label
- 2 Healthy Eating Control
- description
- Equal time and attention, information about healthy eating and general conversation
- interventionNames
- Behavioral: Healthy Eating Control
Primary outcomes (1)
- measure
- Fatigue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- RESULTBerger 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 17397701
- RESULTBerger 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 17573292