Sleep Management in Cancer Survivors - Full Text View

Sponsor:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00935376

Purpose

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:

the mind-body bridging program (MBBP),
mindfulness meditation program (MMP), and
sleep education program (SEP).

Condition	Intervention	Phase
Insomnia	Behavioral: Sleep Education Program Behavioral: Mind-Body Bridging Program Behavioral: Mindfulness Meditation Program	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Medical Outcomes Study-Sleep Scale [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ] [ Designated as safety issue: No ]
Functional Assessment of Cancer Therapy - General [ Time Frame: Pre-treatment, Post treatment, Follow up ] [ Designated as safety issue: No ]
Perceived Stress Scale [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Impact of Event Scale [ Time Frame: Pre-treatment, Post treatment, Follow up ] [ Designated as safety issue: No ]
Center for Epidemiologic Studies Depression Scale [ Time Frame: Pre-treatment, Post treatment, Follow up ] [ Designated as safety issue: No ]
Positive Affect-Negative Affect [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ] [ Designated as safety issue: No ]
Five-factor Mindfulness Questionnaire [ Time Frame: Pre-treatment, Post treatment, Follow up ] [ Designated as safety issue: No ]
Self-Compassion Scale [ Time Frame: Pre-treatment, Post treatment, Follow up ] [ Designated as safety issue: No ]
Well-Being Index [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2009
Study Completion Date:	July 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. Other Name: MBBP
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 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. Other Name: MMP
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 Treatment as usual. Other Name: 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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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).
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.
Participant must be English speaking and comprehend information presented during the course of study, including the consent form.

Exclusion Criteria:

Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia.
Use of psychotropic medication for any of the above, and for any other unspecified condition.
Has had previous exposure to MBBP or MBSR/MMP.
Incidence of metastatic cancer
Currently taking immuno-suppressants and/or corticosteroids.
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.
Individuals who are considered at the 'end-of-life' stage of their cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935376

Locations

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

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Yoshio Nakamura, Ph.D.

University of Utah

More Information

No publications provided

Responsible Party:	Yoshio Nakamura, Ph.D., University of Utah
ClinicalTrials.gov Identifier:	NCT00935376 History of Changes
Other Study ID Numbers:	33669, 5R21 AT002209
Study First Received:	June 18, 2009
Last Updated:	September 14, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Sleep Management
Awareness Training Programs
Mindfulness Meditation
Mind Body Bridging

ClinicalTrials.gov processed this record on May 23, 2012