Clinical trial · Interventional
Home-Based Programs for Improving Sleep in Cancer Survivors
A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors. PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.
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 |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-based sleep intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Home-based sleep intervention with Device #1
- description
- Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
- interventionNames
- Behavioral: Home-based sleep intervention
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Home-based sleep intervention with Device #2
- description
- Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
- interventionNames
- Behavioral: Home-based sleep intervention
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Prior diagnosis of cancer * At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy) * Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex) * Concurrent trastuzumab and maintenance rituximab allowed * Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on 3 out of 7 nights in a week * No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for \> 30 consecutive days in the year before cancer diagnosis * No active cancer (i.e., not considered no evidence of disease) * No concurrent CNS malignancy * No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Availability of a CD player and head or earphones * Ability to complete questionnaires * No uncontrolled chronic pain (i.e., pain score of ≥ 4 on Numeric Analogue Sleep and Pain Scale) * No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia per medical record * No hot flashes that interrupt sleep * Not working overnight hours and unable to change schedule * No emotional, psychological, or physical state that, according to physician and/or study personnel evaluation, would preclude adherence to daily home intervention implementation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 days since prior corticosteroid, including inhaled steroids, of any dose for \> 2 days * No prior experience with guided imagery or cognitive behavioral therapy for insomnia * No concurrent new herbal therapies * Stable dose of daily herbal supplements started ≥ 8 weeks before study intervention allowed * Herbal teas or herbs in various drink products allowed * No concurrent treatment with variable doses of any of the following: * Antidepressants * Anxiolytics * Pain medication (not including over the counter ad anti-inflammatory pain relievers) * Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4 weeks before study entry, and can be used daily or intermittently
References
Publications (1)
- DERIVEDBarton DL, Atherton PJ, Satele DV, Qin R, Dakhil S, Pipe T, Hobday T, Fee-Schroeder K, Loprinzi CL. A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance). Support Care Cancer. 2020 Dec;28(12):6085-6094. doi: 10.1007/s00520-020-05461-6. Epub 2020 Apr 19. PMID 32307658