Psychological DistressCOMFORTNCT05518591
COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence
A study testing Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR) in people with Psychological Distress and Cancer Recurrence, run by University College Dublin at 1 site in Ireland.
Trial summary
The purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Cancer Recurrence
- What is being tested?
- Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIreland
- Study dates
- 25 Mar 2022to Jun 2023
- 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
- adults aged 18 or older
- pre-existing cancer diagnosis
- diagnosis of cancer recurrence during COVID-19 (March 2020 onwards)
- Living in Ireland
- English speaking / fluency
- Access to web / tech support
Who cannot join
- A score <4 on the Distress Thermometer
- Patient non-consent
- The presence of a severe mental illness (such as schizophrenia, personality disorder or active illness)
- Known or suspected drug or alcohol abuse problems within past 3 months
- Inability to follow the study procedures e.g. dementia or non-fluency of English
- Life expectancy <3 months
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin
Donal Brennan, PhD, 01 716 4576, donal.brennan@ucd.ie
Donal Brennan, PhD
About this study
Official title: A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.
The purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic.
Read the detailed description
This study plans to study how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the pandemic, having previously been diagnosed with cancer. We know that a cancer diagnosis can often result in significant psychological distress. After or during treatment for cancer, individuals often experience a 'fear of recurrence', which should it occur, often results in a state of mental anguish that is described as being more punishing than the initial diagnosis itself. Being diagnosed with a cancer recurrence diagnosis can trigger marked negative psychological symptoms, including distress, uncertainty, traumatic distress and adjustment problems, with psychological recovery from this diagnosis often being slower than that of the initial cancer diagnosis. The COVID-19 pandemic has affected these patients further, in terms of restricted access to healthcare, reduced social supports, and greater levels of treatment uncertainty. Our research team has designed a psychological intervention that is specifically aimed to help some of these issues. It's a 6-week online group intervention using a 'compassion focused therapy' approach, coupled with specialised breathing techniques to reduce bodily distress. It is being done online due to ongoing concerns around COVID but also to eliminate geographical and/or commuting barriers. It is our expectation that those receiving the psychological intervention will experience noticeable reductions in measures of psychological distress compared to those who are receiving regular treatment. It is our hope that the outcomes of this study will inform how best to help patients facing into cancer recurrence at a national level.
- Conditions
- Psychological Distress, Cancer Recurrence
- Being tested
- Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)Behavioural
Study participants in the experimental arm of the study are being asked to take part in a 6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. Each group session lasts less than two hours, per week.
| Study group | Role | What they receive |
|---|---|---|
| CFT & BPR | Experimental | 6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. Receives: Behavioral: Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR) |
| Treatment As Usual | No intervention | Those in the treatment as usual arm are not being asked to engage in anything additional to their regular treatment plan. They will, however, be given the option to participate in the psychological intervention after the study has ended, if they elect to do so. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Distress Score
The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)
Measured: 12 weeks post completion of intervention
Secondary outcomes (4)
Changes in depressive symptoms
Patient Health Questionnaire-9 (PHQ-9) will assesses symptoms of depression
Measured: 12 weeks post completion of intervention
Changes in anxiety symptoms
General Anxiety Disorder-7 (GAD-7) will assesses symptoms of anxiety
Measured: 12 weeks post completion of intervention
Changes in traumatic distress
Impact of Event Scales- Revised (IES-R) will measure the amount of distress that a subject associates with a specific event.
Measured: 12 weeks post completion of intervention
Mental Adjustment to Cancer Recurrence
Mini-Mental Adjustment to Cancer (MAC) scale will measure a subjects ability to cope with diagnosis of recurrence and and assesses five cancer-specific coping strategies.
Measured: 12 weeks post completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start25 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Mater Misericordiae University Hospital, Irish Cancer Society
- Responsible party
- Principal investigator, Donal Brennan, University College Dublin
- Investigators
- Sinead Lynch, PhD, Principal investigator, MMUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518591
- Sponsor's protocol ID
- COV21LYN
- Acronym
- COMFORT
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lynch S, Lowry D, Finnerty C, O'Meara Y, Brennan D. The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID. Trials. 2023 Feb 6;24(1):89. doi: 10.1186/s13063-023-07088-4.
PubMed 36747246
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.
- ClinicalTrials.gov ID
- NCT05518591
- Acronym / sponsor ID
- COMFORT / COV21LYN
- Conditions
- Psychological Distress, Cancer Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Mater Misericordiae University Hospital, Irish Cancer Society
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Aug 2022 (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 purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic.
Detailed description
This study plans to study how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the pandemic, having previously been diagnosed with cancer. We know that a cancer diagnosis can often result in significant psychological distress. After or during treatment for cancer, individuals often experience a 'fear of recurrence', which should it occur, often results in a state of mental anguish that is described as being more punishing than the initial diagnosis itself. Being diagnosed with a cancer recurrence diagnosis can trigger marked negative psychological symptoms, including distress, uncertainty, traumatic distress and adjustment problems, with psychological recovery from this diagnosis often being slower than that of the initial cancer diagnosis. The COVID-19 pandemic has affected these patients further, in terms of restricted access to healthcare, reduced social supports, and greater levels of treatment uncertainty. Our research team has designed a psychological intervention that is specifically aimed to help some of these issues. It's a 6-week online group intervention using a 'compassion focused therapy' approach, coupled with specialised breathing techniques to reduce bodily distress. It is being done online due to ongoing concerns around COVID but also to eliminate geographical and/or commuting barriers. It is our expectation that those receiving the psychological intervention will experience noticeable reductions in measures of psychological distress compared to those who are receiving regular treatment. It is our hope that the outcomes of this study will inform how best to help patients facing into cancer recurrence at a national level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFT & BPR | Experimental | Behavioral: Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. |
| Treatment As Usual | No intervention | –Those in the treatment as usual arm are not being asked to engage in anything additional to their regular treatment plan. They will, however, be given the option to participate in the psychological intervention after the study has ended, if they elect to do so. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults aged 18 or older
- pre-existing cancer diagnosis
- diagnosis of cancer recurrence during COVID-19 (March 2020 onwards)
- Living in Ireland
- English speaking / fluency
Key exclusion criteria (6 listed)
- A score <4 on the Distress Thermometer
- Patient non-consent
- The presence of a severe mental illness (such as schizophrenia, personality disorder or active illness)
- Known or suspected drug or alcohol abuse problems within past 3 months
- Inability to follow the study procedures e.g. dementia or non-fluency of English
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 |
|---|---|---|
| Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)Study participants in the experimental arm of the study are being asked to take part in a 6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. Each group session lasts less than two hours, per week. | Behavioural | CFT & BPR |
Primary outcome
Overall Distress Score
Time frame: 12 weeks post completion of intervention
The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)
4 secondary outcomes
Changes in depressive symptoms
Time frame: 12 weeks post completion of intervention
Changes in anxiety symptoms
Time frame: 12 weeks post completion of intervention
Changes in traumatic distress
Time frame: 12 weeks post completion of intervention
Mental Adjustment to Cancer Recurrence
Time frame: 12 weeks post completion of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 36747246Lynch S, Lowry D, Finnerty C, O'Meara Y, Brennan D. The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID. Trials. 2023 Feb 6;24(1):89. doi: 10.1186/s13063-023-07088-4.
- Individual participant dataSharing planned: No
Related trials for Psychological Distress
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
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.
Sinead Lynch, PhD principal investigator
MMUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR) in people with Psychological Distress and Cancer Recurrence, run by University College Dublin at 1 site in Ireland.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Aug 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donal Brennan, PhD (01 716 4576, donal.brennan@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Distress Score (time frame: 12 weeks post completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518591, which also lists 1 linked publication.
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 26 Aug 2022.