Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Breast Cancer Clinical Trial

Official title:

Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601548
• Other study ID #: 2012NTLS014
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

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