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Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors

NCT02786797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2020-07-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress reduction intervention, in order to determine its efficacy in improving cognitive functioning among breast cancer survivors. The study will employ a three group randomized design that will (1) evaluate the extent to which MBSR(BC) compared to the Breast Cancer-Education Support (BCES) program or Usual Care (UC) improves cognitive functioning among breast cancer survivors off treatment; (2) determine if improvements in cognitive functioning achieved from MBSR(BC) are mediated through increased mindfulness and decreased rumination and stress; (3) evaluate genetic variants as moderators of MBSR(BC) on improvements in CI; and (4) determine the impact of MBSR(BC) on healthcare utilization and costs, in addition it will be delivered to a sub-group in Spanish. If shown to be efficacious, the possibility exists of utilizing this intervention in other types of cancers as well as non-cancer health-related disorders in order to minimize the morbidity experienced by these populations.

Conditions

Interventions

BEHAVIORAL

MBSR(BC) 6 Week Program

The MBSR(BC) is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. It incorporates simple yoga, sitting meditation, body scan, and walking meditation in this program. Classes for this intervention occur on a weekly basis for 2 hours for 6 weeks. The participants will be asked to record their informal/formal practices in a daily diary during the program and from 6 weeks to 6 months after the intervention.

BEHAVIORAL

BCES 6 Week Program

The BCES is an education support program. This 6-week program is based on the published NIH program, "Support for People with Cancer: Taking Time Education Support Group." In addition the class sessions consist of group discussion of educational materials and homework assignments; and group processes related to sharing supportive care situations. The participants will record their feelings, coping mechanisms, and questions related to survivorship in a daily diary during the program and from 6 weeks to 6 months after the intervention.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02786797 on ClinicalTrials.gov