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Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients


Inclusion Criteria:



- Study participants must be women diagnosed with Stage I, II, or III breast cancer
within the previous 18 months, have completed all treatments with the exception of
hormonal therapy at least three months previously, over the age of 18, and have a
score of 13 or higher on the BSI-18. Previous meditation/yoga experience is allowed
but will be recorded.

Exclusion Criteria:

- Participants must not have a concurrent DSM-IV diagnosis of psychosis, substance
abuse, bipolar disorder, or active suicidality (as assessed by structured clinical
interview), must not be currently using psychotropic medications (antipsychotics,
antidepressants, anxiolytics), have a concurrent autoimmune disorder, or have
participated previously in MBSR or SET group.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality

Principal Investigator

Linda E Carlson, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

20444

NCT ID:

NCT00390169

Start Date:

October 2006

Completion Date:

July 2009

Related Keywords:

  • Breast Neoplasms
  • breast neoplasms
  • stress
  • personality
  • psychology
  • Breast Neoplasms
  • Neoplasms

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