Clinical trial · Interventional
The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
NCT06604247CI-TRIAL-00080765completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.
Conditions
Conditions (2)
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 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral therapy for insomnia (CBT-I) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 4-session
- description
- Participants randomized to this condition received 4 weekly CBT-I sessions.
- interventionNames
- Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
- type
- EXPERIMENTAL
- label
- 8-session
- description
- Participants randomized to this condition received 8 weekly CBT-I sessions.
- interventionNames
- Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
- type
- EXPERIMENTAL
- label
- 10-session
- description
- Participants randomized to this condition received 10 weekly CBT-I sessions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of organ-confined breast cancer or prostate cancer * Received radiation treatment * Willing and able to provide informed consent * Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory Exclusion Criteria: * History of obstructive Sleep Apnea * History of narcolepsy * Night shift work * Distant metastatic disease at presentation * Active drug/alcohol dependence
References
Publications (0)
Data not yet available
No reference posted for this study.