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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01591915
• Other study ID #: 499-09
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 2, 2012
• Last updated: April 29, 2016
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: April 2016
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skaraborg Hospital	Skövde	Western Region

Sponsors (1)

Lead Sponsor	Collaborator
Skaraborg Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of Mindfulness Based Stress Reduction on mood disorders		up to 5 years follow up	No
Secondary	Coping capacity and health-related quality of life		up to 5 years follow up	No