Clinical trial · Interventional
Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
NCT01929720CI-TRIAL-00026804FOCUScompletedN/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)
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Cognitive-behavioral Therapy | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Insomnia | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Ovarian Neoplasm | Ovarian Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive-behavioral therapy for worry, uncertainty & insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (CBT for worry, uncertainty & insomnia)
- description
- Patients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. Patients participate in a Behavioral Intervention (cognitive-behavioral therapy) in which they receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5.
- interventionNames
- Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia
- type
- ACTIVE_COMPARATOR
- label
- Arm II (wait-list control)
- description
- Patients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. This is a wait-list comparison, so after six weeks, patients in the control group complete the behavioral (cognitive-behavioral therapy)intervention for worry, uncertainty, and insomnia.
- interventionNames
- Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * lung cancer * stage III or IV colorectal cancer * pancreatic cancer * esophageal cancer * multiple myeloma * leukemia * stage IIIC and IV melanoma * ovarian cancer * stage III \& IV cervical cancer * stage III \& IV uterine cancer * stage IIIB, IIIC, and IV breast cancer * glioblastoma multiforme * early relapse (\< 1 year) lymphoma Exclusion Criteria: * co-morbid immunologic disease (i.e. rheumatoid arthritis, systemic lupus) * neurologic disease (i.e. multiple sclerosis, Parkinson's, Alzheimer's) that would affect neuro-immune assessment or completion of study questionnaires * mania (if patient has bipolar disorder) * active substance abuse disorders such as alcohol dependence and cocaine abuse will also be excluded
References
Publications (2)
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811
- DERIVEDWells-Di Gregorio S, Flowers S, Peng J, Marks DR, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson W, Magalang U, Baltimore S, Ancoli-Israel S. Combined Treatment With Cognitive Behavioral Therapy for Insomnia and Acceptance and Commitment Therapy Enhances Objective and Subjective Reports of Sleep in Patients With Advanced Cancer. Psychooncology. 2025 Apr;34(4):e70141. doi: 10.1002/pon.70141. PMID 40204663