Sleep Management in Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors

NCT02613364

Cancer Survivor Insomnia Malignant Neoplasm

COMPLETED NA

Survivorship Sleep Program

NCT04566068

Cancer Insomnia

COMPLETED NA

A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer

NCT01335776

Cancer Insomnia

COMPLETED NA

Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

NCT06807086

Insomnia Chronic

RECRUITING NA

Innovating CBT-I for Cancer Survivors: An Optimization Trial

NCT06181643

Cancer Survivorship Insomnia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mind-Body Bridging Program

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Mindfulness Meditation Program

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Sleep Education Program

Intervention Type BEHAVIORAL

Treatment as usual.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep Education Program

Treatment as usual.

Intervention Type BEHAVIORAL

Mind-Body Bridging Program

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SEP MBBP MMP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes