Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

November 29, 2017 updated by: Masonic Cancer Center, University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1, Week 8 and 4 Month Follow-Up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1, Week 8 and 4 Month Follow-Up
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
Day 1, Week 8 and 4 Month Follow-Up
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
Day 1, Week 8 and 4 Month Follow-Up
Comparison of Sexual Functioning Scale Scores - Intervention versus Control
Time Frame: Day 1, Week 8 and 4 Month Follow-Up
MOS Sexual Functioning Scale
Day 1, Week 8 and 4 Month Follow-Up
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
Day 1, Week 8 and 4 Month Follow-Up
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.
Day 1, Week 8 and 4 Month Follow-Up
Change in Number of Natural Killer Cells - Intervention versus Control
Time Frame: Day 1, Week 8 and 4 Month Follow-Up
Day 1, Week 8 and 4 Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Anne Blaes, M.D., Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (ESTIMATE)

May 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012NTLS014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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