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

Lead sponsor

Prisma Health-Upstate is the lead sponsor of 74 studies on the registry; 7 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Study arms

• 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

• 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.

Interventions

• BehavioralMindfulness-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.

  Also known as: 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

   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.

   Time frame: 5 months

2. Change in stress level measured by cortisol levels collected from self-administering saliva collection kits

   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.

   Time frame: 5 months

3. Change in inflammation measured by analyzing blood samples collected pre and post intervention using inflammation markers

   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.

   Time frame: 5 months

Secondary outcomes

1. Changes in diet measured by the National Cancer Institute's fat and fruit and vegetables screeners

   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.

   Time frame: 5 months

2. Change in sleep quality measured using the Pittsburgh Sleep Quality Index

   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.

   Time frame: 5 months

3. Change in level of stress measured by the Center for Epidemiologic Studies Depression Scale [CES-D 10]

   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.

   Time frame: 5 months

4. Change in level of stress measured by the Perceived Stress Scale (PSS)

   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.

   Time frame: 5 months

Other outcomes

1. Change in meditation habits and awareness measured by the Mindful Attention Awareness Scale (MASS)

   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.

   Time frame: 5 months