Clinical trial NCT02633748: Mindfulness Intervention to Improve Symptomology Among Cancer Survivors; Focus on Sleep and Stress Improvement
Official title: Mindfulness Intervention to Improve Symptomology Among Cancer Survivors; Focus on Sleep and Stress Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Sequelae
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: University of Georgia
name: University of South Carolina
First posted: 2015-12-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 5 months
measure: Change in stress level measured by cortisol levels collected from self-administering saliva collection kits
timeFrame: 5 months
measure: Change in inflammation measured by analyzing blood samples collected pre and post intervention using inflammation markers
timeFrame: 5 months
Secondary outcomes:
measure: Changes in diet measured by the National Cancer Institute's fat and fruit and vegetables screeners
timeFrame: 5 months
measure: Change in sleep quality measured using the Pittsburgh Sleep Quality Index
timeFrame: 5 months
measure: Change in level of stress measured by the Center for Epidemiologic Studies Depression Scale [CES-D 10]
timeFrame: 5 months
measure: Change in level of stress measured by the Perceived Stress Scale (PSS)
timeFrame: 5 months
Other outcomes:
measure: Change in meditation habits and awareness measured by the Mindful Attention Awareness Scale (MASS)
timeFrame: 5 months
Locations:
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Mark O'Rourke, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Georgia
name: Sara Robb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina
name: Michael Wirth, PhD
role: PRINCIPAL_INVESTIGATOR
References: