CClinicalTrials.gg
Status unknownNCT01591915Updated May 2, 2016

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

An interventional study of MBSR in Breast Cancer, sponsored by Skaraborg Hospital. Status unknown at 1 site in Sweden. Open to female participants. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Skaraborg Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 150 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Skaraborg Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with advanced illness at diagnosis
  • patients previously used MBSR
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    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.

    Other: MBSR

  • Experimental
    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.

    Other: MBSR

  • No intervention
    Standard care

Interventions

  • OtherMBSR

    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.

06

What researchers measure

Primary outcomes

  1. The efficacy of Mindfulness Based Stress Reduction on mood disorders

    Time frame: up to 5 years follow up

Secondary outcomes

  1. Coping capacity and health-related quality of life

    Time frame: up to 5 years follow up

07

Study locations

1 site
  • Skaraborg Hospital
    Skövde, Western Region SE-541 85, Sweden
08

References and documents

Publications

  • 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. PubMed 24088535 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01591915
Lead sponsor
Skaraborg Hospital
Responsible party
Elisabeth Kenne Sarenmalm (Researcher, Skaraborg Hospital) — Principal investigator
First posted
May 4, 2012
Start date
Jan 2010
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
May 2, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion