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Completed

NCT Number: NCT02633748

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

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.

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Key information

Conditions

Cancer Sequelae

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mindfulness-Based Cancer Survivorship

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • University of Georgia
  • University of South Carolina

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Oct 10, 2016

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.