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A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors

Phase 1/Phase 2
18 Years
65 Years
Not Enrolling

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Trial Information

A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors

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

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Medical Outcomes Study-Sleep Scale

Outcome Time Frame:

Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

Safety Issue:


Principal Investigator

Yoshio Nakamura, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

July 2010

Related Keywords:

  • Insomnia
  • Sleep Management
  • Awareness Training Programs
  • Mindfulness Meditation
  • Mind Body Bridging



Yoshio Nakamura, Ph.D. Salt Lake City, Utah  84108