Sleep Management in Cancer Survivors

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Mind-Body Bridging Program; Behavioral: Sleep Education Program; Behavioral: Mindfulness Meditation Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00935376

33669

5R21AT002209 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 57 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 3 patient groups

Mind-Body Bridging Program

Experimental group

Description:

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.

Treatment:

Behavioral: Mind-Body Bridging Program

Mindfulness Meditation Program

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Meditation Program

Sleep Education Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Education Program