Sleep Management in Cancer Survivors

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935376
• Other study ID #: 33669
• Secondary ID: 5R21AT002209
• Status: Completed
• Phase: N/A
• First received: June 18, 2009
• Last updated: April 14, 2017
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Sleep Education Program
Treatment as usual.
• Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
• 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.

Locations

Country	Name	City	State
United States	Yoshio Nakamura, Ph.D.	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Outcomes Study-Sleep Scale		Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Primary	Functional Assessment of Cancer Therapy - General		Pre-treatment, Post treatment, Follow up
Primary	Perceived Stress Scale		Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Secondary	Impact of Event Scale		Pre-treatment, Post treatment, Follow up
Secondary	Center for Epidemiologic Studies Depression Scale		Pre-treatment, Post treatment, Follow up
Secondary	Positive Affect-Negative Affect		Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Secondary	Five-factor Mindfulness Questionnaire		Pre-treatment, Post treatment, Follow up
Secondary	Self-Compassion Scale		Pre-treatment, Post treatment, Follow up
Secondary	Well-Being Index		Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up