Mindfulness for People With Incurable Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Mindfulness for health

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancaster, United Kingdom
    • Royal Lancaster Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness group; Group will receive mindfulness intervention	Behavioral: Mindfulness for health; A course of mindfulness using the mindfulness for health programme.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lancaster University
• Collaborators: University Hospitals of Morecambe Bay NHS Trust; Rosemere Cancer Foundation, UK

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Palliative care; Mindfulness
• Other Study ID Numbers: IRASProject ID: 226702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No