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

NCT ID: NCT01591915

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MBSR

Intervention Type 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

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

Group Type EXPERIMENTAL

MBSR

Intervention Type 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.

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Skaraborg Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Elisabeth Kenne Sarenmalm

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Skaraborg Hospital

Skövde, Western Region, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 24088535 (View on PubMed)

Other Identifiers

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499-09

Identifier Type: -

Identifier Source: org_study_id

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