Mindfulness Intervention to Improve Symptomology Among Cancer Survivors; Focus on Sleep and Stress Improvement

October 7, 2016 updated by: Prisma Health-Upstate
Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors. This study will enroll cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to undergo the Mindfulness Based Cancer Survivorship (MBCS) four-week program, with assessments before, immediately after, and three months after the intervention. Results of the study will be used to develop new care models that improve cancer survivor stress and symptoms using mindfulness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cancer survivors suffer with stress, fatigue, sleep complaints, pain, and many other adverse health effects. Chronic stress is detrimental to quality of life and, potentially, length of survival among cancer survivors. Mindfulness-Based Cancer Survivorship (MBCS) is a four-week standardized mindfulness program, adapted for cancer survivors from Mindfulness-Based Stress Reduction (MBSR). MBCS teaches formal mindfulness practice (meditation) and informal mindfulness during daily activities. Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors. This study will enroll cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to undergo the MBCS four-week mindfulness program, with assessments before, immediately after, and three months after the intervention. The assessments will include 1) questionnaires to measure lifestyle, stress, meditation habits, and sleep impairment, 2) blood tests to measure various biomarkers (e.g., inflammatory cytokines), 3) using a BodyMedia's Sensewear® armband for a week to measure sleep and physical activity, and 4) salivary cortisol levels. The forty participants will be randomized to either the intervention arm, the four-week MBCS mindfulness program, or the control arm, a brief control/breathing course. After the three month post assessment, participants in the control arm will have the opportunity to take the MBCS course. Results of the study will be used to develop new care models that improve cancer survivor stress and symptoms using mindfulness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a cancer survivor
  • Ability to read, write, and understand English
  • Ability to participate in a group

Exclusion Criteria:

  • Previous experience in a MBCS course
  • Corticosteroid therapy greater than prednisone 25 mg per day or equivalent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Intervention
The twenty participants in the intervention arm will undergo a pre-assessment, post assessment, and a three month follow-up assessment. The pre and post assessments will ask participants to 1) fill out questionnaires to measure lifestyle, stress, meditations habits, and sleep impairment, 2) take a blood sample, 3) use a BodyMedia's Sensewear® armband for a week, and 4) provide salivary cortisol levels. The three month follow-up will repeat everything done if the first two assessments, excluding the blood sample. The intervention arm will also attend the weekly two and a half hour Mindfulness-Based Cancer Survivorship (MBSC) four-week program between the pre and post assessments.
Behavioral: Mindfulness-Based Cancer Survivorship
Mindfulness-Based Cancer Survivorship (MBCS) is a four-week standardized mindfulness program, adapted for cancer survivors from Mindfulness-Based Stress Reduction (MBSR). MBCS teaches formal mindfulness practice (meditation) and informal mindfulness during daily activities. Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors.
Other Names:
  • MBCS
No Intervention: Control
The twenty participants in the control arm will undergo the same pre assessment as the intervention arm, receive a presentation on breathing exercises, and undergo the same post and three-month follow-up assessments. The control arm will also be offered the same Mindfulness-Based Cancer Survivorship program given to the intervention arm following the three month follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in physical activity as measured by a Body Sensewear actigraph wore by the participants for a week pre-intervention, post intervention, and at a three month follow-up
Time Frame: 5 months
All 40 participants will wear a BodyMedia's Sensewear® armband for a week at three different points in the study. The actigraphs collect data on physical activity by measuring, calories burned, minutes of vigorous activity, and hours of sleep. Data such as height and weight are collected before administering armband to measure data accurately. The data will be analyzed using SenseWear Pro 8.1 software and SAS v9.4.
5 months
Change in stress level measured by cortisol levels collected from self-administering saliva collection kits
Time Frame: 5 months
Participants will collect six serial saliva samples pre-invention, post-intervention, and at the 3-month follow-up. The first four samples will be taken within the first hour of waking (first upon awakening, 15, 30, and 45 minutes after waking). Participants will collect the last two samples one hour before dinner and one right before they go to bed. All saliva samples will then be shipped to the University of Georgia for cortisol characterization.
5 months
Change in inflammation measured by analyzing blood samples collected pre and post intervention using inflammation markers
Time Frame: 5 months
Approximately 5ml of blood will be collected from each participant at the pre and post assessment. The samples will be collected in a yellow top serum separator tube (SST). Immediately following the blood draw, samples will be inverted gently 5 times and then stored upright to allow for clotting for a minimum of 30 minutes. For processing, after balancing the centerfigure, the samples will be spun at 3,000 rpm for 15 minutes at 4⁰C. After spinning, 1 ml of serum will be transferred into a cryovials using a clean pipet. All cryovials will be stored at -80 in a freezer. All samples will then be transported to School of Medicine, University of South Carolina where they will be analyzed using inflammation markers.
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in diet measured by the National Cancer Institute's fat and fruit and vegetables screeners
Time Frame: 5 months
The NCI questionnaire will be administered at pre-intervention, post-intervention (5 weeks later), and at a 3 month follow-up succeeding the post-intervention data collection. The data collected from pre-intervention to the three-month follow up will take place in a 5 month timespan.
5 months
Change in sleep quality measured using the Pittsburgh Sleep Quality Index
Time Frame: 5 months
The Pittsburgh Sleep Quality Index questionnaire will be administered at pre-intervention, post-intervention (5 weeks later), and at a 3 month follow-up succeeding the post-intervention data collection. The data collected from pre-intervention to the three-month follow up will take place in a 5 month timespan.
5 months
Change in level of stress measured by the Center for Epidemiologic Studies Depression Scale [CES-D 10]
Time Frame: 5 months
The CES-D 10 will be administered at pre-intervention, post-intervention (5 weeks later), and at a 3 month follow-up succeeding the post-intervention data collection. The data collected from pre-intervention to the three-month follow up will take place in a 5 month timespan.
5 months
Change in level of stress measured by the Perceived Stress Scale (PSS)
Time Frame: 5 months
The PSS questionnaire will be administered at pre-intervention, post-intervention (5 weeks later), and at a 3 month follow-up succeeding the post-intervention data collection. The data collected from pre-intervention to the three-month follow up will take place in a 5 month timespan.
5 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in meditation habits and awareness measured by the Mindful Attention Awareness Scale (MASS)
Time Frame: 5 months
The MASS questionnaire will be administered at pre-intervention, post-intervention (5 weeks later), and at a 3 month follow-up succeeding the post-intervention data collection. The data collected from pre-intervention to the three-month follow up will take place in a 5 month timespan.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prisma Health-Upstate

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of South Carolina
University of Georgia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark O'Rourke, M.D., Prisma Health-Upstate
  • Principal Investigator: Sara Robb, PhD, University of Georgia
  • Principal Investigator: Michael Wirth, PhD, University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00047213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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