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Completed

NCT Number: NCT03446092

Mindfulness 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Lancaster Infirmary

Lancaster, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness for health

Behavioral

A course of mindfulness using the mindfulness for health programme.

Primary outcomes

  1. Acceptability and usefulness of intervention for participants

    Time frame: Within 4 weeks of the end of the intervention

    This will be a qualitative outcome, collected via semi-structured interview

Secondary outcomes

  1. Acceptability and usefulness of intervention for participants- 3 months

    Time frame: 3 months following completion of the intervention

    This will be a qualitative outcome, collected via semi-structured interview

  2. Change in depression anxiety and stress

    Time frame: 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.

  3. Change in depression anxiety and stress-3 months

    Time frame: 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.

  4. Change in mindfulness

    Time frame: 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.

  5. Change in mindfulness- 3 months

    Time frame: 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

  6. Change in quality of life

    Time frame: 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

  7. Change in quality of life - 3 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lancaster University

Other

Collaborators

  • Rosemere Cancer Foundation, UK
  • University Hospitals of Morecambe Bay NHS Trust

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 26, 2018
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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