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Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.
MBCR is a step wise standardized behavioral intervention of MBSR. The program is usually conducted in eight weekly class sessions that are 2-2.5 hours in length. During class sessions, participants are presented with mindfulness meditation techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. In addition to home meditation practice there are often reading assignments and reflective exercises that relate to mindfulness. A full day retreat generally occurs in the second half of the course, providing an opportunity for class participants to gain extended experience with mindfulness techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Subjects are randomized to the Mindfulness Based Cancer Recovery (MBSR) intervention. Participants are presented with mindfulness medication techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. A full day silent retreat will occur in the second half of the course, providing an opportunity for class participants to gain experience with mindfulness techniques. |
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| Control Arm | No Intervention | No intervention is administered. Health-related quality of life questionnaires will be completed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Cancer Recovery | Behavioral | Defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being. MBCR is a psycho-educational program developed by Dr. Linda Carlson. It is a step by step mindful-based stress reduction program (MBSR) designed to help cancer patients cope with their cancer diagnosis and treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medical Outcomes Study Scores - Intervention versus Control | MOS SF-36: Medical Outcomes Study 36-Item Short-Form | Day 1, Week 8 and 4 Month Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control | FACT-F: Functional Assessment in Cancer Therapy - Fatigue | Day 1, Week 8 and 4 Month Follow-Up |
| Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Blaes, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
PSQI: Pittsburgh Sleep Quality Index |
| Day 1, Week 8 and 4 Month Follow-Up |
| Change in State-Trait Anxiety Inventory Scores - Intervention versus Control | 20-item State-Trait Anxiety Inventory | Day 1, Week 8 and 4 Month Follow-Up |
| Comparison of Sexual Functioning Scale Scores - Intervention versus Control | MOS Sexual Functioning Scale | Day 1, Week 8 and 4 Month Follow-Up |
| Change in Self-Compassion Scale Scores - Intervention versus Control | SCS-SF: Self-Compassion Scale - Short Form | Day 1, Week 8 and 4 Month Follow-Up |
| Change in Self-Collected Information - Intervention versus Control | Self collected and self-report information regarding weekly meditation practice time, recorded class attendance and information from participants regarding barriers and challenges to practice, and perceived benefits to practice will be collected. | Day 1, Week 8 and 4 Month Follow-Up |
| Change in Number of Natural Killer Cells - Intervention versus Control | Day 1, Week 8 and 4 Month Follow-Up |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014591 | Uterine Diseases |