Clinical trial · Interventional
Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy
Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study never funded
Summary
Brief summary (as posted)
Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect their mood, their memory and their quality of life. The investigators are testing whether it is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and quality of life.
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 |
|---|---|---|---|
| Stage, Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief behavioral treatment for insomnia and bright light | Behavioral | — | UNRESOLVED |
| treatment as usual | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment-as-usual
- description
- Treatment as usual for fatigue and insomnia
- interventionNames
- Behavioral: treatment as usual
- type
- ACTIVE_COMPARATOR
- label
- Behavioral treatment
- description
- Brief behavioral treatment for insomnia and bright light Light and BBTI combined treatment for insomnia and fatigue
- interventionNames
- Behavioral: Brief behavioral treatment for insomnia and bright light
Primary outcomes (1)
- measure
- fatigue
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * stage I-III breast cancer referred for chemotherapy * English speaking * over age 18 Exclusion Criteria: 1. Pregnancy (by self-report; poor sleep and fatigue are sometimes associated with pregnancy); 2. Metastatic or unresectable breast cancer; 3. Patients who have been told they have sleep apnea, restless legs or periodic limb movements in sleep whether or not they are currently treated; 4. History of bipolar disorder or history of mania; 5. Current diagnosis of psychotic disorder; 6. Blindness or other physical or psychological impairments which would limit participation; 7. Shift workers; 8. Women with infants who still disturb the mother's sleep.
References
Publications (0)
Data not yet available