Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

NCT01601548 | Completed

• 1 other identifier: 2012NTLS014
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer; Ovarian Cancer; Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Day 1, Week 8 and 4 Month Follow-Up

• Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control

  Day 1, Week 8 and 4 Month Follow-Up

• Change in State-Trait Anxiety Inventory Scores - Intervention versus Control

  Day 1, Week 8 and 4 Month Follow-Up

• Comparison of Sexual Functioning Scale Scores - Intervention versus Control

  Day 1, Week 8 and 4 Month Follow-Up

• Change in Self-Compassion Scale Scores - Intervention versus Control

  Day 1, Week 8 and 4 Month Follow-Up

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

No intervention is administered. Health-related quality of life questionnaires will be completed.

Interventions

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Psychologic disease in which informed consent cannot be obtained from the subject
• Need for ongoing chemotherapy and/or radiation therapy

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Blaes, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: May 18, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

US (1)