NCT00935376

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

June 18, 2009

Last Update Submit

April 14, 2017

Conditions

Insomnia

Keywords

Sleep ManagementAwareness Training ProgramsMindfulness MeditationMind Body Bridging

Outcome Measures

Primary Outcomes (3)

  • Medical Outcomes Study-Sleep Scale

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

  • Functional Assessment of Cancer Therapy - General

    Pre-treatment, Post treatment, Follow up

  • Perceived Stress Scale

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

Secondary Outcomes (6)

  • Impact of Event Scale

    Pre-treatment, Post treatment, Follow up

  • Center for Epidemiologic Studies Depression Scale

    Pre-treatment, Post treatment, Follow up

  • Positive Affect-Negative Affect

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

  • Five-factor Mindfulness Questionnaire

    Pre-treatment, Post treatment, Follow up

  • Self-Compassion Scale

    Pre-treatment, Post treatment, Follow up

  • +1 more secondary outcomes

Study Arms (3)

Mind-Body Bridging Program

EXPERIMENTAL

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

Mindfulness Meditation Program

EXPERIMENTAL

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

Sleep Education Program

ACTIVE COMPARATOR

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

Sleep Education ProgramBEHAVIORAL

Treatment as usual.

Also known as: SEP
Sleep Education Program
Mind-Body Bridging ProgramBEHAVIORAL

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

Also known as: MBBP
Mind-Body Bridging Program
Mindfulness Meditation ProgramBEHAVIORAL

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
Mindfulness Meditation Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yoshio Nakamura, Ph.D.

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

  • 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.

    PMID: 23375640DERIVED

  • 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.

    PMID: 23338490DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Matrix Metalloproteinases

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Officials

  • Yoshio Nakamura, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2009

First Posted

July 9, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

July 1, 2010

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)