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Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Primary Purpose

Breast Cancer, Colorectal Cancer, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Cancer Recovery
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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.

No intervention is administered. Health-related quality of life questionnaires will be completed.

Outcomes

Primary Outcome Measures

Change in Medical Outcomes Study Scores - Intervention versus Control
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
FACT-F: Functional Assessment in Cancer Therapy - Fatigue
Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control
PSQI: Pittsburgh Sleep Quality Index
Change in State-Trait Anxiety Inventory Scores - Intervention versus Control
20-item State-Trait Anxiety Inventory
Comparison of Sexual Functioning Scale Scores - Intervention versus Control
MOS Sexual Functioning Scale
Change in Self-Compassion Scale Scores - Intervention versus Control
SCS-SF: Self-Compassion Scale - Short Form
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.
Change in Number of Natural Killer Cells - Intervention versus Control

Full Information

First Posted
April 24, 2012
Last Updated
November 29, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01601548
Brief Title
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
Official Title
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Ovarian Cancer, Uterine Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No intervention is administered. Health-related quality of life questionnaires will be completed.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cancer Recovery
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Medical Outcomes Study Scores - Intervention versus Control
Description
MOS SF-36: Medical Outcomes Study 36-Item Short-Form
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Secondary Outcome Measure Information:
Title
Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control
Description
FACT-F: Functional Assessment in Cancer Therapy - Fatigue
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Title
Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control
Description
PSQI: Pittsburgh Sleep Quality Index
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Title
Change in State-Trait Anxiety Inventory Scores - Intervention versus Control
Description
20-item State-Trait Anxiety Inventory
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Title
Comparison of Sexual Functioning Scale Scores - Intervention versus Control
Description
MOS Sexual Functioning Scale
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Title
Change in Self-Compassion Scale Scores - Intervention versus Control
Description
SCS-SF: Self-Compassion Scale - Short Form
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Title
Change in Self-Collected Information - Intervention versus Control
Description
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.
Time Frame
Day 1, Week 8 and 4 Month Follow-Up
Title
Change in Number of Natural Killer Cells - Intervention versus Control
Time Frame
Day 1, Week 8 and 4 Month Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Blaes, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

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