Mindfulness for People With Incurable Cancer

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Mindfulness for health

• Registration Number: NCT03446092
• Lead Sponsor: Lancaster University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Study Start: 2018-11-19
• Primary Completion: 2019-06-30
• Study Completion: 2020-05-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

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Exclusion Criteria

• Having any other condition or difficulty which the medical team thinks would compromise their participation in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness group	Mindfulness for health	Group will receive mindfulness intervention

Primary Outcome Measures

Name	Time	Method
Acceptability and usefulness of intervention for participants	Within 4 weeks of the end of the intervention	This will be a qualitative outcome, collected via semi-structured interview

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention	Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire we will measure pre-post change scores
Change in depression anxiety and stress	Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention	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.
Change in depression anxiety and stress-3 months	Collected before the intervention (up to 4 weeks before the intervention) and 3 months after the end of the intervention	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.
Change in mindfulness- 3 months	Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention	Using the Five Factor Mindfulness Questionnaire we will measure pre-post change scores
Acceptability and usefulness of intervention for participants- 3 months	3 months following completion of the intervention	This will be a qualitative outcome, collected via semi-structured interview
Change in mindfulness	Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention	Using the Five Factor Mindfulness Questionnaire we will measure pre-post change scores.
Change in quality of life - 3 months	Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention	Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire we will measure pre-post change scores

Trial Locations

Locations (1)

Royal Lancaster Infirmary; 🇬🇧 Lancaster, United Kingdom