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Completed

NCT Number: NCT00935376

Sleep Management in Cancer Survivors

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yoshio Nakamura, Ph.D.

Salt Lake City, Utah, 84108, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep Education Program

Behavioral

Treatment as usual.

Other names: SEP

Mind-Body Bridging Program

Behavioral

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

Other names: MBBP

Mindfulness Meditation Program

Behavioral

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 names: MMP

Primary outcomes

  1. Medical Outcomes Study-Sleep Scale

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

  2. Functional Assessment of Cancer Therapy - General

    Time frame: Pre-treatment, Post treatment, Follow up

  3. Perceived Stress Scale

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

Secondary outcomes

  1. Impact of Event Scale

    Time frame: Pre-treatment, Post treatment, Follow up

  2. Center for Epidemiologic Studies Depression Scale

    Time frame: Pre-treatment, Post treatment, Follow up

  3. Positive Affect-Negative Affect

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

  4. Five-factor Mindfulness Questionnaire

    Time frame: Pre-treatment, Post treatment, Follow up

  5. Self-Compassion Scale

    Time frame: Pre-treatment, Post treatment, Follow up

  6. Well-Being Index

    Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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