Skip to content

A qualitative (feasibility) study of mindfulness based stress reduction (MBSR) for the treatment of fatigue, anxiety and depression in women with metastatic breast cancer

A qualitative (feasibility) study of mindfulness based stress reduction (MBSR) for the treatment of fatigue, anxiety and depression in women with metastatic breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41578109
Enrollment
35
Registered
2011-02-17
Start date
2010-12-06
Completion date
Unknown
Last updated
2022-08-15

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

Conditions

Topic: National Cancer Research Network

Interventions

Mindfulness based stress reduction (MBSR) was developed by Jon Kabat Zinn (University of Massachusetts Medical Center) and is a "specific structured psycho educational and skills based package" that e

Sponsors

Southampton University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. After diagnosis of metastatic breast cancer and stable enough to have a real likelihood of completing the study as assessed by the recruiting oncologists 2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 1, thus excluding bed bound and frail patients 3. Estimated life expectancy of at least 6 months to enable retention and minimise group disruption 4. Able to provide informed written consent 5. Fluent English; the questionnaires are written and validated in English 6. Assessed as eligible by the mindfulness instructor following the clinician's initial approval 7. Female subjects, no age range

Exclusion criteria

Exclusion criteria: 1. Substance misuse or other issues that may jeopardise the health of individuals participating in the intervention will be excluded 2. Comorbitities that makes it unlikely that participants will complete the study (including borderline personality disorder, major psychotic illness) 3. Participants who are felt to be too distressed to be approached will be excluded (this will be determined by the clinicians)

Design outcomes

Primary

MeasureTime frame
Brief Fatigue Inventory, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5

Secondary

MeasureTime frame
1. EORTC-QLQ-C30, measured prior to intervention at baseline and post-intervention at month 5 2. EuroQol EQ5D, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5 3. Hospital Anxiety and Depression Scale, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5 4. Toronto Mindfulness Scale, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026