Clinical trial NCT01601548: Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
Official title: Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Ovarian Cancer
Uterine Cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Medical Outcomes Study Scores - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
Secondary outcomes:
measure: Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
measure: Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
measure: Change in State-Trait Anxiety Inventory Scores - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
measure: Comparison of Sexual Functioning Scale Scores - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
measure: Change in Self-Compassion Scale Scores - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
measure: Change in Self-Collected Information - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
measure: Change in Number of Natural Killer Cells - Intervention versus Control
timeFrame: Day 1, Week 8 and 4 Month Follow-Up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Anne Blaes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: