Clinical trial · Interventional
Sleep Management in Cancer Survivors
A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors
NCT00935376CI-TRIAL-00027037completedN/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 pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are: 1. the mind-body bridging program (MBBP), 2. mindfulness meditation program (MMP), and 3. sleep education program (SEP).
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 |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mind-Body Bridging Program | Behavioral | — | UNRESOLVED |
| Mindfulness Meditation Program | Behavioral | — | UNRESOLVED |
| Sleep Education Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Mind-Body Bridging Program
- description
- The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
- interventionNames
- Behavioral: Mind-Body Bridging Program
- type
- EXPERIMENTAL
- label
- Mindfulness Meditation Program
- description
- Mindfulness Meditation Program (MMP) is based on Mindfulness-Based Stress Reduction (MBSR), which teaches participants mindfulness skills such as meditation and yoga. Mindfulness may be defined as paying attention in a particular way, on purpose, in the present moment, and nonjudgmentally. The goal of MBSR is to provide participants with experiential tools and mindfulness practices to assist them to become more mindful of themselves, others and their external environment. The techniques are easy to learn and teach individuals to be aware of the present moment, with an open mind in which they can perceive their thoughts, physical sensations, and emotions nonjudgmentally.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005). 2. Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2-3 months follow-up. 3. Participant must be English speaking and comprehend information presented during the course of study, including the consent form. Exclusion Criteria: 1. Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia. 2. Use of psychotropic medication for any of the above, and for any other unspecified condition. 3. Has had previous exposure to MBBP or MBSR/MMP. 4. Incidence of metastatic cancer 5. Currently taking immuno-suppressants and/or corticosteroids. 6. Compromised physical health, in which individual has impaired mobility: unable to carry out movement exercises, cannot lie down on the floor, kneel, get up from the floor to a standing position. 7. Individuals who are considered at the 'end-of-life' stage of their cancer.
References
Publications (2)
- DERIVEDLipschitz DL, Kuhn R, Kinney AY, Donaldson GW, Nakamura Y. Reduction in salivary alpha-amylase levels following a mind-body intervention in cancer survivors--an exploratory study. Psychoneuroendocrinology. 2013 Sep;38(9):1521-31. doi: 10.1016/j.psyneuen.2012.12.021. Epub 2013 Feb 1. PMID 23375640
- DERIVEDNakamura Y, Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW. Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2013 Jun;7(2):165-82. doi: 10.1007/s11764-012-0252-8. Epub 2013 Jan 22. PMID 23338490