Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Not Applicable

Completed

• Conditions: Breast Cancer; Ovarian Cancer; Colorectal Cancer; Uterine Cancer
• Interventions: Behavioral: Mindfulness Based Cancer Recovery

• Registration Number: NCT01601548
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-18
• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Mindfulness Based Cancer Recovery	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.

Primary Outcome Measures

Name	Time	Method
Change in Medical Outcomes Study Scores - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up	MOS SF-36: Medical Outcomes Study 36-Item Short-Form

Secondary Outcome Measures

Name	Time	Method
Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up	FACT-F: Functional Assessment in Cancer Therapy - Fatigue
Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up	PSQI: Pittsburgh Sleep Quality Index
Change in State-Trait Anxiety Inventory Scores - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up	20-item State-Trait Anxiety Inventory
Comparison of Sexual Functioning Scale Scores - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up	MOS Sexual Functioning Scale
Change in Self-Compassion Scale Scores - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up	SCS-SF: Self-Compassion Scale - Short Form
Change in Self-Collected Information - Intervention versus Control	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.
Change in Number of Natural Killer Cells - Intervention versus Control	Day 1, Week 8 and 4 Month Follow-Up

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States