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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01601548
Other study ID # 2012NTLS014
Secondary ID
Status Completed
Phase N/A
First received April 24, 2012
Last updated November 29, 2017
Start date July 2012
Est. completion date July 2013

Study information

Verified date November 2017
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
United States Masonic Cancer Center, University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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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