Breast Cancer Clinical Trial
Official title:
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
Verified date | November 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Stage I-III breast cancer, gynecologic cancer or colorectal cancer - Cancer survivor at least 18 years of age at the time of study enrollment - Completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed) Exclusion Criteria: - Psychologic disease in which informed consent cannot be obtained from the subject - Need for ongoing chemotherapy and/or radiation therapy |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control | PSQI: Pittsburgh Sleep Quality Index | Day 1, Week 8 and 4 Month Follow-Up | |
Secondary | 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 | |
Secondary | Comparison of Sexual Functioning Scale Scores - Intervention versus Control | MOS Sexual Functioning Scale | Day 1, Week 8 and 4 Month Follow-Up | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in Number of Natural Killer Cells - Intervention versus Control | Day 1, Week 8 and 4 Month Follow-Up |
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