CancerNCT03446092
Mindfulness for People With Incurable Cancer
A study testing Mindfulness for health in people with Cancer, run by Lancaster University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mindfulness for health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having any other condition or difficulty which the medical team thinks would compromise their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Mindfulness for health
- Keywords
- Cancer, Mindfulness, Palliative care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness for healthBehavioural
A course of mindfulness using the mindfulness for health programme.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | Group will receive mindfulness intervention Receives: Behavioral: Mindfulness for health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and usefulness of intervention for participants
This will be a qualitative outcome, collected via semi-structured interview
Measured: Within 4 weeks of the end of the intervention
Secondary outcomes (7)
Acceptability and usefulness of intervention for participants- 3 months
This will be a qualitative outcome, collected via semi-structured interview
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start19 Nov 2018
- Primary completion30 Jun 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Morecambe Bay NHS Trust, Rosemere Cancer Foundation, UK
- Responsible party
- Principal investigator, Fiona Eccles, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446092
- Sponsor's protocol ID
- IRASProject ID: 226702
- Status last verified
- May 2022
- First submitted
- 13 Feb 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of a Mindfulness Course for People With Incurable Cancer
- ClinicalTrials.gov ID
- NCT03446092
- Acronym / sponsor ID
- IRASProject ID: 226702
- Conditions
- Cancer
- Keywords
- Cancer, Mindfulness, Palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Collaborators
- University Hospitals of Morecambe Bay NHS Trust, Rosemere Cancer Foundation, UK
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Behavioral: Mindfulness for healthGroup will receive mindfulness intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Having any other condition or difficulty which the medical team thinks would compromise their participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness for healthA course of mindfulness using the mindfulness for health programme. | Behavioural | Mindfulness group |
Primary outcome
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
7 secondary outcomes
Acceptability and usefulness of intervention for participants- 3 months
Time frame: 3 months following completion of the intervention
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
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
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
Change in mindfulness- 3 months
Time frame: Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness for health in people with Cancer, run by Lancaster University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and usefulness of intervention for participants (time frame: Within 4 weeks of the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.