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

NCT01591915 | Unknown

• 1 other identifier: 499-09
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life

Outcome Measures

Primary Outcomes (1)

• The efficacy of Mindfulness Based Stress Reduction on mood disorders

  up to 5 years follow up

Secondary Outcomes (1)

• Coping capacity and health-related quality of life

  up to 5 years follow up

Study Arms (3)

MBSR self care program including weekly sessions

EXPERIMENTAL

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.

Other: MBSR

MBSR self care program

EXPERIMENTAL

Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week.

Other: MBSR

Standard care

NO INTERVENTION

Interventions

MBSR OTHER

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.

MBSR self care program; MBSR self care program including weekly sessions

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with advanced illness at diagnosis
• patients previously used MBSR

Sponsors & Collaborators

• Skaraborg Hospital: lead

Study Sites (1)

Skaraborg Hospital

Skövde, Western Region, SE-541 85, Sweden

Location

Related Publications (1)

• Kenne Sarenmalm E, Martensson LB, Holmberg SB, Andersson BA, Oden 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.

  PMID: 24088535 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

SE (1)