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CompletedNCT00935376Updated Apr 18, 2017

Sleep Management in Cancer Survivors

An interventional study of Sleep Education Program and Mind-Body Bridging Program in Insomnia, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-18.

Sponsored by University of Utah · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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).
Read the detailed description

This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).

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Conditions studied

  • Insomnia

Keywords

  • Sleep Management
  • Awareness Training Programs
  • Mindfulness Meditation
  • Mind Body Bridging
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In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Mind-Body Bridging Program

    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.

    Behavioral: Mind-Body Bridging Program

  • Experimental
    Mindfulness Meditation Program

    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.

    Behavioral: Mindfulness Meditation Program

  • Active comparator
    Sleep Education Program

    The Sleep Education Program (SEP) will serve as the control intervention in which participants will receive classes informing them how to change their habits to improve their sleep, and what to do if they have concerns about their sleep quality.

    Behavioral: Sleep Education Program

Interventions

  • BehavioralSleep Education Program

    Treatment as usual.

    Also known as: SEP

  • BehavioralMind-Body Bridging Program

    Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.

    Also known as: MBBP

  • BehavioralMindfulness Meditation Program

    Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga.

    Also known as: MMP

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What researchers measure

Primary outcomes

  1. Medical Outcomes Study-Sleep Scale

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

  2. Functional Assessment of Cancer Therapy - General

    Time frame: Pre-treatment, Post treatment, Follow up

  3. Perceived Stress Scale

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

Secondary outcomes

  1. Impact of Event Scale

    Time frame: Pre-treatment, Post treatment, Follow up

  2. Center for Epidemiologic Studies Depression Scale

    Time frame: Pre-treatment, Post treatment, Follow up

  3. Positive Affect-Negative Affect

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

  4. Five-factor Mindfulness Questionnaire

    Time frame: Pre-treatment, Post treatment, Follow up

  5. Self-Compassion Scale

    Time frame: Pre-treatment, Post treatment, Follow up

  6. Well-Being Index

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

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Study locations

1 site
  • Yoshio Nakamura, Ph.D.
    Salt Lake City, Utah 84108, United States
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References and documents

Publications

  • Lipschitz 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. PubMed 23375640 ↗
  • Nakamura 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. PubMed 23338490 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00935376
Lead sponsor
University of Utah
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Yoshio Nakamura (Assistant Professor, University of Utah) — Principal investigator
First posted
Jul 9, 2009
Start date
May 2009
Primary completion
May 2010
Completion
Jul 2010
Last update
Apr 18, 2017

Study contacts

Yoshio Nakamura, Ph.D.
principal investigator · University of Utah

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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