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

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast; Mental and Behavioural Disorders; Fatigue, anxiety and depression

• Registration Number: ISRCTN41578109
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25161198 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-17
• Study Completion: 2012-10-01
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. EORTC-QLQ-C30, measured prior to intervention at baseline and post-intervention at month 5<br> 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<br> 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<br> 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<br>