Sleep Management in Cancer Survivors

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Mind-Body Bridging Program; Behavioral: Mindfulness Meditation Program; Behavioral: Sleep Education Program

• Registration Number: NCT00935376
• Lead Sponsor: University of Utah

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).

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-09
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind-Body Bridging Program	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.
Mindfulness Meditation Program	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.
Sleep Education Program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Well-Being Index	Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

Trial Locations

Locations (1)

Yoshio Nakamura, Ph.D.; 🇺🇸 Salt Lake City, Utah, United States