Clinical trial NCT00935376: Sleep Management in Cancer Survivors
Official title: A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Sleep Management
Awareness Training Programs
Mindfulness Meditation
Mind Body Bridging
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-07-09
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Medical Outcomes Study-Sleep Scale
timeFrame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
measure: Functional Assessment of Cancer Therapy - General
timeFrame: Pre-treatment, Post treatment, Follow up
measure: Perceived Stress Scale
timeFrame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Secondary outcomes:
measure: Impact of Event Scale
timeFrame: Pre-treatment, Post treatment, Follow up
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Pre-treatment, Post treatment, Follow up
measure: Positive Affect-Negative Affect
timeFrame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
measure: Five-factor Mindfulness Questionnaire
timeFrame: Pre-treatment, Post treatment, Follow up
measure: Self-Compassion Scale
timeFrame: Pre-treatment, Post treatment, Follow up
measure: Well-Being Index
timeFrame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Yoshio Nakamura, Ph.D.
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshio Nakamura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.