Mindfulness for People With Incurable Cancer

Study Overview
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Brief Summary
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The study will investigate whether a mindfulness course can help people with incurable cancer who are seen by oncologists in a particular National Health Service Hospital Trust in the United Kingdom.

Detailed Description
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It can be hard to come to terms with living with a life limiting condition such as incurable cancer and individuals are at risk of experiencing high levels of psychological distress, which can often be overlooked when the focus is on managing physical symptoms. Mindfulness-based interventions have been shown to be helpful in reducing distress for people with cancer generally. This pilot study will use an established mindfulness programme called mindfulness for health with people with cancer which is incurable to see if this type of intervention is acceptable and useful for this group of people.

Official Title
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A Pilot Investigation of a Mindfulness Course for People With Incurable Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Mindfulness for health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deemed by the oncologist to have incurable cancer Patient of the University Hospitals of Morecambe Bay NHS Foundation Trust Treated by an oncologist Believe they are able to commit to attending most of the mindfulness course sessions Oncologist assesses they are well enough to participate in the intervention Exclusion Criteria: Having any other condition or difficulty which the medical team thinks would compromise their participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness group<br>Group will receive mindfulness intervention | Behavioral: Mindfulness for health<br>* A course of mindfulness using the mindfulness for health programme.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and usefulness of intervention for participants | This will be a qualitative outcome, collected via semi-structured interview | Within 4 weeks of the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and usefulness of intervention for participants- 3 months | This will be a qualitative outcome, collected via semi-structured interview | 3 months following completion of the intervention | 
| Change in depression anxiety and stress | Using the Depression, Anxiety and Stress (DASS21) scale we will measure the change post intervention score - pre intervention score. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating higher distress. A greater decrease in scores, would mean a greater improvement in symptoms. | Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention | 
| Change in depression anxiety and stress-3 months | Using the Depression, Anxiety and Stress (DASS21) scale we will measure the change post intervention score - pre intervention score. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating higher distress. A greater decrease in scores, would mean a greater improvement in symptoms. | Collected before the intervention (up to 4 weeks before the intervention) and 3 months after the end of the intervention | 
| Change in mindfulness | Using the Five Factor Mindfulness Questionnaire we will measure pre-post change scores. | Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention | 
| Change in mindfulness- 3 months | Using the Five Factor Mindfulness Questionnaire we will measure pre-post change scores | Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention | 
| Change in quality of life | Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire we will measure pre-post change scores | Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention | 
| Change in quality of life - 3 months | Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire we will measure pre-post change scores | Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Mindfulness, Palliative care