Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Study Overview
=================
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.

Official Title
-----------------
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Conditions
-----------------
Breast Cancer, Colorectal Cancer, Ovarian Cancer, Uterine Cancer

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Cancer Recovery


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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<br>|
| No Intervention: Control Arm<br>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 | 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 | 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 | PSQI: Pittsburgh Sleep Quality Index | Day 1, Week 8 and 4 Month Follow-Up | 
| 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 | 
| Comparison of Sexual Functioning Scale Scores - Intervention versus Control | MOS Sexual Functioning Scale | Day 1, Week 8 and 4 Month Follow-Up | 
| 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 | 
| 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 | 
| Change in Number of Natural Killer Cells - Intervention versus Control |  | Day 1, Week 8 and 4 Month Follow-Up |