Clinical trial · Interventional
Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy
Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT) (SHERE-Relief 2)
- 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)
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Impairment | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SH/ReadiWatchTM | Behavioral | — | UNRESOLVED |
| teleCBT-I + SH/ReadiWatchTM | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- SH/ReadiWatchTM
- description
- Participants receive real-time feedback on sleep metrics and sleep hygiene education
- interventionNames
- Behavioral: SH/ReadiWatchTM
- type
- EXPERIMENTAL
- label
- teleCBT-I + SH/ReadiWatchTM
- description
- Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia
- interventionNames
- Behavioral: teleCBT-I + SH/ReadiWatchTM
Primary outcomes (3)
- measure
- Feasibility as measured by percentage of target sample enrolled
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old * Diagnosed with any stage of prostate cancer * Receiving androgen deprivation therapy * Able to speak and read English * Score \>/= 8 on Insomnia Severity Index Exclusion Criteria: * Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent * Sleep apnea not utilizing/or adherent to CPAP * Uncontrolled restless legs syndrome
References
Publications (0)
Data not yet available