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Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601548
First Posted: May 18, 2012
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
April 24, 2012
May 18, 2012
December 1, 2017
July 2012
July 2013   (Final data collection date for primary outcome measure)
Change in Medical Outcomes Study Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
MOS SF-36: Medical Outcomes Study 36-Item Short-Form
Same as current
Complete list of historical versions of study NCT01601548 on ClinicalTrials.gov Archive Site
  • Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
    FACT-F: Functional Assessment in Cancer Therapy - Fatigue
  • Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
    PSQI: Pittsburgh Sleep Quality Index
  • Change in State-Trait Anxiety Inventory Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
    20-item State-Trait Anxiety Inventory
  • Comparison of Sexual Functioning Scale Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
    MOS Sexual Functioning Scale
  • Change in Self-Compassion Scale Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
    SCS-SF: Self-Compassion Scale - Short Form
  • Change in Self-Collected Information - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
    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.
  • Change in Number of Natural Killer Cells - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ]
Same as current
Not Provided
Not Provided
 
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Uterine Cancer
Behavioral: Mindfulness Based Cancer Recovery
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
  • Experimental: Intervention Arm
    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.
    Intervention: Behavioral: Mindfulness Based Cancer Recovery
  • No Intervention: Control Arm
    No intervention is administered. Health-related quality of life questionnaires will be completed.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01601548
2012NTLS014
No
Not Provided
Not Provided
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Anne Blaes, M.D. Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP