A pilot study of a mindfulness intervention among women in recovery from breast cancer

Mindfulness in rehabilitation of breast cancer: is mindfulness associated with alleviation of psychological symptoms among women in remission?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12326308

Enrollment

Registered

2021-02-16

Start date

2017-01-08

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological symptoms and stress biomarkers among women in remission from breast cancer Mental and Behavioural Disorders

Interventions

MBSR is a structured 8-week program developed for systematic training for mindfulness skills. The program consists of eight weekly group sessions, one day long silent retreat, and mindfulness home pra

learnings from the MBSR course

experienced support from the MBSR group

bodily sensations related to mindfulness practice

verbal description of the experience of mindfulness practice

personal conception of the mindfulness practice) at the program completion (8 weeks after baseline). Background characteristics such as health status, medication, employment and social support are col

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women (aged 25-65 years) with curatively treated, operated invasive breast cancer (T1-4 N0-3 M0) 1 year earlier 2. Self-reported depressive symptoms (BDI-II score >13 points) 3. Motivation to attend

Exclusion criteria

Exclusion criteria: 1. Metastatic disease 2. Lack of motivation to attend 3. Substance abuse 4. Suicidality 5. Psychotic symptoms 6. Untreated posttraumatic stress disorder 7. Severe social phobia

Design outcomes

Primary

Measure	Time frame
Measured at baseline before the start of the MBSR program, mid-program (4 weeks after baseline), and at the program completion (8 weeks after baseline): 1. Psychological symptoms and mental wellbeing assessed by the following self-reported questionnaires: 1.1. Depression symptoms measured using the Beck Depression Inventory-II (BDI-II) 1.2. Anxiety measured using the Beck Anxiety Inventory (BAI) 1.3. Insomnia measured using the Insomnia Severity Index (ISI) 1.4. Stress measured using the Perceived Stress Scale (PSS-10) 1.5. Quality of life measured using the World Health Organization Quality of Life–questionnaire (WHOQOL-BREF) 1.6. Resilience measured using the Resilience Scale 1.7. Self-compassion measured using the Self-compassion Scale, short form (SCS-SF) 1.8. Mindfulness skills measured using the Five Facet Mindfulness Questionnaire (FFMQ) 2. Stress and low-grade inflammation assessed using the following biomarkers: cortisol (sera), adrenocorticotropine (sera), hs-CRP (sera), 24-hour- cortisol (urine)	—

Measure

Time frame

Measured at baseline before the start of the MBSR program, mid-program (4 weeks after baseline), and at the program completion (8 weeks after baseline): 1. Psychological symptoms and mental wellbeing assessed by the following self-reported questionnaires: 1.1. Depression symptoms measured using the Beck Depression Inventory-II (BDI-II) 1.2. Anxiety measured using the Beck Anxiety Inventory (BAI) 1.3. Insomnia measured using the Insomnia Severity Index (ISI) 1.4. Stress measured using the Perceived Stress Scale (PSS-10) 1.5. Quality of life measured using the World Health Organization Quality of Life–questionnaire (WHOQOL-BREF) 1.6. Resilience measured using the Resilience Scale 1.7. Self-compassion measured using the Self-compassion Scale, short form (SCS-SF) 1.8. Mindfulness skills measured using the Five Facet Mindfulness Questionnaire (FFMQ) 2. Stress and low-grade inflammation assessed using the following biomarkers: cortisol (sera), adrenocorticotropine (sera), hs-CRP (sera), 24-hour- cortisol (urine)

—

Secondary

Measure	Time frame
1. Quantity of independent mindfulness practice (time in minutes) collected with a written diary filled in by the participants every day during the 8-week program (8 x 7), i.e. 56 timepoints 2. Experiences of mindfulness practice and the MBSR program gathered in a written format by eight open-ended questions at the program completion (8 weeks after baseline): 1. Did you have difficult experiences related to mindfulness practice? 2. If you had difficult experience/s related to mindfulness practice, how did it/they affect your life? 3. The most important learnings from the MBSR course to you? 4. Do you apply learnings from the MBSR course to your everyday life? 5. Do you feel that you received support from the members of the MBSR group? 6. Did you have bodily sensations related to mindfulness practice? 7. Are you able to verbalize your mindfulness experience? 8. Do understand mindfulness practice similarly or differently compared to your understanding prior to attending the MBSR program?	—

Measure

Time frame

1. Quantity of independent mindfulness practice (time in minutes) collected with a written diary filled in by the participants every day during the 8-week program (8 x 7), i.e. 56 timepoints 2. Experiences of mindfulness practice and the MBSR program gathered in a written format by eight open-ended questions at the program completion (8 weeks after baseline): 1. Did you have difficult experiences related to mindfulness practice? 2. If you had difficult experience/s related to mindfulness practice, how did it/they affect your life? 3. The most important learnings from the MBSR course to you? 4. Do you apply learnings from the MBSR course to your everyday life? 5. Do you feel that you received support from the members of the MBSR group? 6. Did you have bodily sensations related to mindfulness practice? 7. Are you able to verbalize your mindfulness experience? 8. Do understand mindfulness practice similarly or differently compared to your understanding prior to attending the MBSR program?

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Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026