Mindfulness for People With Incurable Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446092
• Other study ID #: IRASProject ID: 226702
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2022
• Source: Lancaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Mindfulness for health
A course of mindfulness using the mindfulness for health programme.

Locations

Country	Name	City	State
United Kingdom	Royal Lancaster Infirmary	Lancaster

Sponsors (3)

Lead Sponsor	Collaborator
Lancaster University	Rosemere Cancer Foundation, UK, University Hospitals of Morecambe Bay NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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