Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01601548
First received: April 24, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Ovarian Cancer
Uterine Cancer
Behavioral: Mindfulness Based Cancer Recovery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Change in Medical Outcomes Study Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ] [ Designated as safety issue: No ]
    MOS SF-36: Medical Outcomes Study 36-Item Short-Form


Secondary Outcome Measures:
  • Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    MOS Sexual Functioning Scale

  • Change in Self-Compassion Scale Scores - Intervention versus Control [ Time Frame: Day 1, Week 8 and 4 Month Follow-Up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Control Arm
No intervention is administered. Health-related quality of life questionnaires will be completed.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601548

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Anne Blaes, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01601548     History of Changes
Other Study ID Numbers: 2012NTLS014
Study First Received: April 24, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases

ClinicalTrials.gov processed this record on July 24, 2014