Clinical Trials Directory

Trials / Completed

CompletedNCT02633748

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Prisma Health-Upstate · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness-Based Cancer SurvivorshipMindfulness-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.

Timeline

Start date
2015-09-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2015-12-17
Last updated
2016-10-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02633748. Inclusion in this directory is not an endorsement.