A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Skaraborg Hospital
Sponsor:
Information provided by (Responsible Party):
Elisabeth Kenne Sarenmalm, Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT01591915
First received: May 2, 2012
Last updated: May 3, 2012
Last verified: May 2012

May 2, 2012
May 3, 2012
January 2010
December 2014   (final data collection date for primary outcome measure)
The efficacy of Mindfulness Based Stress Reduction on mood disorders [ Time Frame: up to 5 years follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01591915 on ClinicalTrials.gov Archive Site
Coping capacity and health-related quality of life [ Time Frame: up to 5 years follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer

The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
Other: MBSR
Participants in Intervention 1 and Intervention 2 will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 min sessions, 6 days/week. Participants will be provided information material including a book of 20 pages introduction to mindfulness training, self-instructing CD, diary and training program. Only participants in Intervention 1 will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 h. Led by a certified MBSR instructor, these weekly group sessions are focused on participant's experiences of mindfulness, and include yoga and meditation training. Four registered nurses, skilled in patient learning, have been educated as certified MBSR instructors.
  • Experimental: MBSR self care program including weekly sessions
    Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. Participants will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 hours.
    Intervention: Other: MBSR
  • Experimental: MBSR self care program
    Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week.
    Intervention: Other: MBSR
  • No Intervention: Standard care
    Intervention: Other: MBSR
Kenne Sarenmalm E, Mårtensson LB, Holmberg SB, Andersson BA, Odén A, Bergh I. Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. BMC Complement Altern Med. 2013 Oct 2;13:248. doi: 10.1186/1472-6882-13-248.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2020
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy

Exclusion Criteria:

  • patients with advanced illness at diagnosis
  • patients previously used MBSR
Female
Not Provided
No
Contact: Elisabeth Kenne Sarenmalm, PhD +46 500 432968 elisabeth.kenne.sarenmalm@vgregion.se
Sweden
 
NCT01591915
499-09
No
Elisabeth Kenne Sarenmalm, Skaraborg Hospital
Skaraborg Hospital
Not Provided
Not Provided
Skaraborg Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP