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Completed

NCT Number: NCT01601548

Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Cancer Recovery

Behavioral

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

Primary outcomes

  1. Change in Medical Outcomes Study Scores - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

    MOS SF-36: Medical Outcomes Study 36-Item Short-Form

Secondary outcomes

  1. Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

    FACT-F: Functional Assessment in Cancer Therapy - Fatigue

  2. Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

    PSQI: Pittsburgh Sleep Quality Index

  3. Change in State-Trait Anxiety Inventory Scores - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

    20-item State-Trait Anxiety Inventory

  4. Comparison of Sexual Functioning Scale Scores - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

    MOS Sexual Functioning Scale

  5. Change in Self-Compassion Scale Scores - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

    SCS-SF: Self-Compassion Scale - Short Form

  6. Change in Self-Collected Information - Intervention versus Control

    Time frame: 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.

  7. Change in Number of Natural Killer Cells - Intervention versus Control

    Time frame: Day 1, Week 8 and 4 Month Follow-Up

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 18, 2012
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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